Trial Outcomes & Findings for First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants (NCT NCT05163522)
NCT ID: NCT05163522
Last Updated: 2025-07-30
Results Overview
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
Up to Day 49
Results posted on
2025-07-30
Participant Flow
Participant milestones
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
Healthy participants were given a dose of placebo once daily (QD) for a 14-day period and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 100 mg PiB
Healthy participants were given a dose of 100 mg VH4004280 PiB QD for a 14-day period and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB
Healthy participants were given a dose of 250 mg VH4004280 PiB QD for a 14-day period, and a single dose of Midazolam on days 1, 2, and 15, and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 350 mg PiB
Healthy participants were given a dose of 350 mg VH4004280 PiB QD for a 14-day period and were followed up to approximately Day 63.
|
Part 3 (Single Dose): VH4004280 450 mg Tablet
Healthy participants were given a single oral dose of VH4004280 450 mg tablet at Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
7
|
6
|
6
|
6
|
6
|
6
|
8
|
6
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
8
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
Healthy participants were given a dose of placebo once daily (QD) for a 14-day period and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 100 mg PiB
Healthy participants were given a dose of 100 mg VH4004280 PiB QD for a 14-day period and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB
Healthy participants were given a dose of 250 mg VH4004280 PiB QD for a 14-day period, and a single dose of Midazolam on days 1, 2, and 15, and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 350 mg PiB
Healthy participants were given a dose of 350 mg VH4004280 PiB QD for a 14-day period and were followed up to approximately Day 63.
|
Part 3 (Single Dose): VH4004280 450 mg Tablet
Healthy participants were given a single oral dose of VH4004280 450 mg tablet at Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=10 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
n=6 Participants
Healthy participants were given a dose of placebo once daily (QD) for a 14-day period and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 100 mg PiB
n=6 Participants
Healthy participants were given a dose of 100 mg VH4004280 PiB QD for a 14-day period and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB
n=8 Participants
Healthy participants were given a dose of 250 mg VH4004280 PiB QD for a 14-day period, and a single dose of Midazolam on days 1, 2, and 15, and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 350 mg PiB
n=6 Participants
Healthy participants were given a dose of 350 mg VH4004280 PiB QD for a 14-day period and were followed up to approximately Day 63.
|
Part 3 (Single Dose): VH4004280 450 mg Tablet
n=6 Participants
Healthy participants were given a single oral dose of VH4004280 450 mg tablet at Day 1 and were followed up to approximately Day 49.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.0 YEARS
STANDARD_DEVIATION 7.21 • n=99 Participants
|
33.8 YEARS
STANDARD_DEVIATION 8.13 • n=107 Participants
|
30.0 YEARS
STANDARD_DEVIATION 9.36 • n=206 Participants
|
31.5 YEARS
STANDARD_DEVIATION 6.28 • n=7 Participants
|
27.7 YEARS
STANDARD_DEVIATION 6.44 • n=31 Participants
|
31.5 YEARS
STANDARD_DEVIATION 6.02 • n=30 Participants
|
36.2 YEARS
STANDARD_DEVIATION 7.68 • n=3 Participants
|
33.5 YEARS
STANDARD_DEVIATION 9.09 • n=6 Participants
|
34.0 YEARS
STANDARD_DEVIATION 10.74 • n=114 Participants
|
42.3 YEARS
STANDARD_DEVIATION 11.08
|
43.5 YEARS
STANDARD_DEVIATION 7.06 • n=19 Participants
|
34.27 YEARS
STANDARD_DEVIATION 8.898 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
6 Participants
|
5 Participants
n=19 Participants
|
72 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
3 Participants
|
3 Participants
n=19 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
3 Participants
|
1 Participants
n=19 Participants
|
28 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received 1 full dose of study treatment. The participants were analyzed according to the treatment they actually received.
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a study intervention whether or not considered related to the study intervention. The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=10 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Any Adverse Events (AEs) and by Severity
Any AEs
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Any Adverse Events (AEs) and by Severity
Grade 1 AEs
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Any Adverse Events (AEs) and by Severity
Grade 2 AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Any Adverse Events (AEs) and by Severity
Grade 3 AEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Any Adverse Events (AEs) and by Severity
Grade 5 AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Any Adverse Events (AEs) and by Severity
Grade 4 AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 63Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 2 (MAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they actually received.
The DAIDS Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Any AEs and by Severity
Any AEs
|
3 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Any AEs and by Severity
Grade 4 AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Any AEs and by Severity
Grade 1 AEs
|
3 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Any AEs and by Severity
Grade 2 AEs
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Any AEs and by Severity
Grade 3 AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Any AEs and by Severity
Grade 5 AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 3 (Single Dose) who received 1 single dose of study treatment. The participants were analyzed according to the treatment they actually received.
The DAIDS Table for Grading the Severity of Adult and Pediatric AE was used for all AE severity grading, where Grade 1=Mild symptoms causing no or minimal interference with usual social \& functional activities with intervention not indicated, 2=Moderate symptoms causing greater than minimal interference with usual social \& functional activities with intervention indicated, 3=Severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated, 4=Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death, 5=Death.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With Any AEs and by Severity
Any AEs
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Any AEs and by Severity
Grade 1 AEs
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Any AEs and by Severity
Grade 2 AEs
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Any AEs and by Severity
Grade 3 AEs
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Any AEs and by Severity
Grade 4 AEs
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Any AEs and by Severity
Grade 5 AEs
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 63Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 2 (MAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they actually received.
Number of participants who discontinued treatment due to AEs are presented.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants Discontinuing Treatment Due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received 1 full dose of study treatment. The participants were analyzed according to the treatment they actually received. Only those participants with data available at specified time points were analyzed for the specific category titles.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Standard Deviation (SD)=0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=10 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 49
|
14.0505 Micromoles per liter (μmol/L)
Standard Deviation 7.95429
|
—
|
—
|
8.8350 Micromoles per liter (μmol/L)
Standard Deviation 3.94512
|
14.8200 Micromoles per liter (μmol/L)
Standard Deviation 6.47967
|
12.7680 Micromoles per liter (μmol/L)
Standard Deviation 8.27588
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 6
|
2.5650 Micromoles per liter (μmol/L)
Standard Deviation 0.68400
|
2.6505 Micromoles per liter (μmol/L)
Standard Deviation 0.69038
|
2.3085 Micromoles per liter (μmol/L)
Standard Deviation 0.77045
|
1.7955 Micromoles per liter (μmol/L)
Standard Deviation 0.89673
|
2.3655 Micromoles per liter (μmol/L)
Standard Deviation 0.98182
|
2.8785 Micromoles per liter (μmol/L)
Standard Deviation 1.17190
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 7
|
2.8899 Micromoles per liter (μmol/L)
Standard Deviation 1.24216
|
2.4795 Micromoles per liter (μmol/L)
Standard Deviation 0.63753
|
2.2800 Micromoles per liter (μmol/L)
Standard Deviation 0.70643
|
1.9095 Micromoles per liter (μmol/L)
Standard Deviation 0.75253
|
2.3370 Micromoles per liter (μmol/L)
Standard Deviation 1.26894
|
2.5935 Micromoles per liter (μmol/L)
Standard Deviation 0.95770
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 14
|
2.3598 Micromoles per liter (μmol/L)
Standard Deviation 0.77234
|
1.7100 Micromoles per liter (μmol/L)
Standard Deviation 0.00000
|
1.5732 Micromoles per liter (μmol/L)
Standard Deviation 0.37072
|
1.6245 Micromoles per liter (μmol/L)
Standard Deviation 0.86351
|
2.2230 Micromoles per liter (μmol/L)
Standard Deviation 0.29618
|
2.6790 Micromoles per liter (μmol/L)
Standard Deviation 1.60291
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 21
|
2.5308 Micromoles per liter (μmol/L)
Standard Deviation 1.19238
|
2.1375 Micromoles per liter (μmol/L)
Standard Deviation 0.95974
|
2.3085 Micromoles per liter (μmol/L)
Standard Deviation 0.94747
|
1.4250 Micromoles per liter (μmol/L)
Standard Deviation 0.49166
|
2.4795 Micromoles per liter (μmol/L)
Standard Deviation 0.83598
|
2.0520 Micromoles per liter (μmol/L)
Standard Deviation 0.98529
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 28
|
2.8215 Micromoles per liter (μmol/L)
Standard Deviation 1.67400
|
2.0805 Micromoles per liter (μmol/L)
Standard Deviation 0.97585
|
2.3256 Micromoles per liter (μmol/L)
Standard Deviation 0.81651
|
1.6530 Micromoles per liter (μmol/L)
Standard Deviation 0.51490
|
3.2490 Micromoles per liter (μmol/L)
Standard Deviation 1.34646
|
2.3370 Micromoles per liter (μmol/L)
Standard Deviation 0.88304
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 35
|
2.3598 Micromoles per liter (μmol/L)
Standard Deviation 1.25348
|
2.1090 Micromoles per liter (μmol/L)
Standard Deviation 0.69810
|
2.2800 Micromoles per liter (μmol/L)
Standard Deviation 0.91556
|
1.7385 Micromoles per liter (μmol/L)
Standard Deviation 0.83364
|
2.2800 Micromoles per liter (μmol/L)
Standard Deviation 1.00682
|
1.9494 Micromoles per liter (μmol/L)
Standard Deviation 0.76090
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 42
|
2.9355 Micromoles per liter (μmol/L)
Standard Deviation 2.10105
|
—
|
—
|
1.6530 Micromoles per liter (μmol/L)
Standard Deviation 0.69810
|
2.7360 Micromoles per liter (μmol/L)
Standard Deviation 1.38499
|
2.7645 Micromoles per liter (μmol/L)
Standard Deviation 1.44053
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
2.5650 Micromoles per liter (μmol/L)
Standard Deviation 1.20915
|
1.9950 Micromoles per liter (μmol/L)
Standard Deviation 0.69810
|
2.9314 Micromoles per liter (μmol/L)
Standard Deviation 0.83439
|
2.2800 Micromoles per liter (μmol/L)
Standard Deviation 1.39621
|
2.2800 Micromoles per liter (μmol/L)
Standard Deviation 0.88304
|
2.8500 Micromoles per liter (μmol/L)
Standard Deviation 0.88304
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 2
|
2.7170 Micromoles per liter (μmol/L)
Standard Deviation 1.24620
|
2.5080 Micromoles per liter (μmol/L)
Standard Deviation 0.59891
|
2.9559 Micromoles per liter (μmol/L)
Standard Deviation 1.17113
|
2.0520 Micromoles per liter (μmol/L)
Standard Deviation 1.03734
|
2.7360 Micromoles per liter (μmol/L)
Standard Deviation 0.93661
|
3.0780 Micromoles per liter (μmol/L)
Standard Deviation 1.27507
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 3
|
2.7018 Micromoles per liter (μmol/L)
Standard Deviation 1.15078
|
2.4795 Micromoles per liter (μmol/L)
Standard Deviation 0.51584
|
2.7075 Micromoles per liter (μmol/L)
Standard Deviation 0.98776
|
1.8525 Micromoles per liter (μmol/L)
Standard Deviation 1.07834
|
2.3655 Micromoles per liter (μmol/L)
Standard Deviation 0.87472
|
3.0495 Micromoles per liter (μmol/L)
Standard Deviation 1.23033
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 4
|
2.4966 Micromoles per liter (μmol/L)
Standard Deviation 1.36847
|
2.0235 Micromoles per liter (μmol/L)
Standard Deviation 0.79043
|
2.7360 Micromoles per liter (μmol/L)
Standard Deviation 0.87193
|
1.9836 Micromoles per liter (μmol/L)
Standard Deviation 0.73151
|
2.2515 Micromoles per liter (μmol/L)
Standard Deviation 1.11566
|
2.6790 Micromoles per liter (μmol/L)
Standard Deviation 1.02410
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 5
|
2.7360 Micromoles per liter (μmol/L)
Standard Deviation 1.18198
|
2.6505 Micromoles per liter (μmol/L)
Standard Deviation 0.63753
|
2.5080 Micromoles per liter (μmol/L)
Standard Deviation 0.73085
|
1.9665 Micromoles per liter (μmol/L)
Standard Deviation 0.81472
|
2.8215 Micromoles per liter (μmol/L)
Standard Deviation 0.75512
|
2.8215 Micromoles per liter (μmol/L)
Standard Deviation 0.98381
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 49
|
2.9355 Micromoles per liter (μmol/L)
Standard Deviation 1.48452
|
—
|
—
|
1.5675 Micromoles per liter (μmol/L)
Standard Deviation 0.58657
|
2.6505 Micromoles per liter (μmol/L)
Standard Deviation 1.15852
|
2.6505 Micromoles per liter (μmol/L)
Standard Deviation 1.49759
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
13.1670 Micromoles per liter (μmol/L)
Standard Deviation 6.84237
|
12.5400 Micromoles per liter (μmol/L)
Standard Deviation 3.84908
|
14.9014 Micromoles per liter (μmol/L)
Standard Deviation 3.65613
|
12.2550 Micromoles per liter (μmol/L)
Standard Deviation 8.47558
|
11.6850 Micromoles per liter (μmol/L)
Standard Deviation 5.00498
|
10.8300 Micromoles per liter (μmol/L)
Standard Deviation 5.26132
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 2
|
14.8770 Micromoles per liter (μmol/L)
Standard Deviation 7.69405
|
11.9130 Micromoles per liter (μmol/L)
Standard Deviation 3.49052
|
13.4357 Micromoles per liter (μmol/L)
Standard Deviation 4.91245
|
10.7730 Micromoles per liter (μmol/L)
Standard Deviation 6.63074
|
17.9835 Micromoles per liter (μmol/L)
Standard Deviation 7.41865
|
16.2735 Micromoles per liter (μmol/L)
Standard Deviation 7.49161
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 3
|
14.2956 Micromoles per liter (μmol/L)
Standard Deviation 6.79530
|
11.7705 Micromoles per liter (μmol/L)
Standard Deviation 3.38635
|
12.1410 Micromoles per liter (μmol/L)
Standard Deviation 4.37573
|
10.4595 Micromoles per liter (μmol/L)
Standard Deviation 7.28983
|
15.5040 Micromoles per liter (μmol/L)
Standard Deviation 7.42594
|
15.5895 Micromoles per liter (μmol/L)
Standard Deviation 6.56018
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 4
|
13.6287 Micromoles per liter (μmol/L)
Standard Deviation 8.26482
|
9.4620 Micromoles per liter (μmol/L)
Standard Deviation 3.81091
|
14.2215 Micromoles per liter (μmol/L)
Standard Deviation 6.54322
|
10.6704 Micromoles per liter (μmol/L)
Standard Deviation 7.32172
|
15.8460 Micromoles per liter (μmol/L)
Standard Deviation 5.98125
|
13.5090 Micromoles per liter (μmol/L)
Standard Deviation 6.44718
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 5
|
13.5603 Micromoles per liter (μmol/L)
Standard Deviation 6.89113
|
11.6565 Micromoles per liter (μmol/L)
Standard Deviation 3.15571
|
11.8275 Micromoles per liter (μmol/L)
Standard Deviation 4.79461
|
10.6875 Micromoles per liter (μmol/L)
Standard Deviation 5.85984
|
15.7320 Micromoles per liter (μmol/L)
Standard Deviation 7.04470
|
14.7345 Micromoles per liter (μmol/L)
Standard Deviation 5.17813
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 6
|
12.9618 Micromoles per liter (μmol/L)
Standard Deviation 4.88926
|
12.1125 Micromoles per liter (μmol/L)
Standard Deviation 3.92990
|
9.6330 Micromoles per liter (μmol/L)
Standard Deviation 3.97319
|
9.3480 Micromoles per liter (μmol/L)
Standard Deviation 6.12902
|
13.9365 Micromoles per liter (μmol/L)
Standard Deviation 7.53701
|
14.3640 Micromoles per liter (μmol/L)
Standard Deviation 5.24388
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 7
|
13.8510 Micromoles per liter (μmol/L)
Standard Deviation 7.21180
|
10.6020 Micromoles per liter (μmol/L)
Standard Deviation 3.25350
|
9.9465 Micromoles per liter (μmol/L)
Standard Deviation 2.53730
|
10.7160 Micromoles per liter (μmol/L)
Standard Deviation 5.72854
|
16.6725 Micromoles per liter (μmol/L)
Standard Deviation 8.20640
|
12.5400 Micromoles per liter (μmol/L)
Standard Deviation 4.43239
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 14
|
10.4139 Micromoles per liter (μmol/L)
Standard Deviation 2.46942
|
6.7545 Micromoles per liter (μmol/L)
Standard Deviation 3.25125
|
7.2846 Micromoles per liter (μmol/L)
Standard Deviation 2.33087
|
7.9515 Micromoles per liter (μmol/L)
Standard Deviation 4.34050
|
11.1150 Micromoles per liter (μmol/L)
Standard Deviation 0.91289
|
11.7990 Micromoles per liter (μmol/L)
Standard Deviation 7.42857
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 21
|
12.4317 Micromoles per liter (μmol/L)
Standard Deviation 5.82742
|
9.6045 Micromoles per liter (μmol/L)
Standard Deviation 5.04078
|
10.2885 Micromoles per liter (μmol/L)
Standard Deviation 3.37424
|
7.5525 Micromoles per liter (μmol/L)
Standard Deviation 3.38980
|
12.4830 Micromoles per liter (μmol/L)
Standard Deviation 4.36636
|
8.9205 Micromoles per liter (μmol/L)
Standard Deviation 3.94920
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 28
|
13.1670 Micromoles per liter (μmol/L)
Standard Deviation 9.01537
|
9.1200 Micromoles per liter (μmol/L)
Standard Deviation 4.86394
|
10.1916 Micromoles per liter (μmol/L)
Standard Deviation 4.40238
|
7.9800 Micromoles per liter (μmol/L)
Standard Deviation 2.95720
|
16.7580 Micromoles per liter (μmol/L)
Standard Deviation 9.74550
|
11.4000 Micromoles per liter (μmol/L)
Standard Deviation 3.21674
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 35
|
12.0042 Micromoles per liter (μmol/L)
Standard Deviation 7.37960
|
8.5785 Micromoles per liter (μmol/L)
Standard Deviation 3.90002
|
10.0605 Micromoles per liter (μmol/L)
Standard Deviation 3.87143
|
8.4360 Micromoles per liter (μmol/L)
Standard Deviation 4.45476
|
11.3715 Micromoles per liter (μmol/L)
Standard Deviation 7.28046
|
8.7552 Micromoles per liter (μmol/L)
Standard Deviation 2.95786
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 42
|
14.8485 Micromoles per liter (μmol/L)
Standard Deviation 12.01166
|
—
|
—
|
8.2080 Micromoles per liter (μmol/L)
Standard Deviation 4.29070
|
15.5895 Micromoles per liter (μmol/L)
Standard Deviation 10.02324
|
12.9675 Micromoles per liter (μmol/L)
Standard Deviation 6.50917
|
PRIMARY outcome
Timeframe: Up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received 1 full dose of study treatment. The participants were analyzed according to the treatment they actually received. Only those participants with data available at specified time points were analyzed for the specific category titles.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALP, ALT and AST.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=10 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Baseline (Day 1)
|
51.8 International units per liter (IU/L)
Standard Deviation 9.39
|
64.7 International units per liter (IU/L)
Standard Deviation 10.88
|
67.1 International units per liter (IU/L)
Standard Deviation 27.91
|
69.0 International units per liter (IU/L)
Standard Deviation 25.04
|
64.0 International units per liter (IU/L)
Standard Deviation 11.10
|
61.8 International units per liter (IU/L)
Standard Deviation 15.41
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 3
|
48.2 International units per liter (IU/L)
Standard Deviation 4.57
|
58.8 International units per liter (IU/L)
Standard Deviation 11.20
|
56.2 International units per liter (IU/L)
Standard Deviation 21.44
|
63.0 International units per liter (IU/L)
Standard Deviation 21.25
|
55.8 International units per liter (IU/L)
Standard Deviation 10.76
|
52.5 International units per liter (IU/L)
Standard Deviation 10.29
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 4
|
49.3 International units per liter (IU/L)
Standard Deviation 6.60
|
60.5 International units per liter (IU/L)
Standard Deviation 12.08
|
60.5 International units per liter (IU/L)
Standard Deviation 19.36
|
58.6 International units per liter (IU/L)
Standard Deviation 18.84
|
63.2 International units per liter (IU/L)
Standard Deviation 10.57
|
52.8 International units per liter (IU/L)
Standard Deviation 11.86
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 5
|
48.1 International units per liter (IU/L)
Standard Deviation 8.16
|
59.2 International units per liter (IU/L)
Standard Deviation 10.32
|
54.7 International units per liter (IU/L)
Standard Deviation 20.65
|
63.3 International units per liter (IU/L)
Standard Deviation 21.16
|
60.5 International units per liter (IU/L)
Standard Deviation 9.57
|
57.7 International units per liter (IU/L)
Standard Deviation 9.16
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 6
|
48.8 International units per liter (IU/L)
Standard Deviation 6.44
|
62.5 International units per liter (IU/L)
Standard Deviation 10.99
|
56.3 International units per liter (IU/L)
Standard Deviation 21.10
|
63.0 International units per liter (IU/L)
Standard Deviation 19.15
|
62.3 International units per liter (IU/L)
Standard Deviation 10.01
|
54.5 International units per liter (IU/L)
Standard Deviation 7.40
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 7
|
51.7 International units per liter (IU/L)
Standard Deviation 7.30
|
64.3 International units per liter (IU/L)
Standard Deviation 13.60
|
61.7 International units per liter (IU/L)
Standard Deviation 17.18
|
64.3 International units per liter (IU/L)
Standard Deviation 20.25
|
66.3 International units per liter (IU/L)
Standard Deviation 11.41
|
56.8 International units per liter (IU/L)
Standard Deviation 7.44
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 14
|
54.8 International units per liter (IU/L)
Standard Deviation 11.85
|
62.2 International units per liter (IU/L)
Standard Deviation 6.97
|
59.6 International units per liter (IU/L)
Standard Deviation 19.49
|
65.0 International units per liter (IU/L)
Standard Deviation 21.48
|
66.4 International units per liter (IU/L)
Standard Deviation 12.72
|
61.3 International units per liter (IU/L)
Standard Deviation 8.62
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 21
|
53.0 International units per liter (IU/L)
Standard Deviation 11.18
|
58.7 International units per liter (IU/L)
Standard Deviation 9.50
|
62.2 International units per liter (IU/L)
Standard Deviation 29.88
|
66.0 International units per liter (IU/L)
Standard Deviation 22.33
|
61.5 International units per liter (IU/L)
Standard Deviation 12.05
|
59.2 International units per liter (IU/L)
Standard Deviation 8.70
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 28
|
53.9 International units per liter (IU/L)
Standard Deviation 12.35
|
57.5 International units per liter (IU/L)
Standard Deviation 7.97
|
66.2 International units per liter (IU/L)
Standard Deviation 43.85
|
65.5 International units per liter (IU/L)
Standard Deviation 22.95
|
63.5 International units per liter (IU/L)
Standard Deviation 10.82
|
65.5 International units per liter (IU/L)
Standard Deviation 11.33
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 35
|
52.9 International units per liter (IU/L)
Standard Deviation 8.69
|
66.3 International units per liter (IU/L)
Standard Deviation 12.80
|
62.3 International units per liter (IU/L)
Standard Deviation 28.22
|
63.8 International units per liter (IU/L)
Standard Deviation 23.56
|
64.7 International units per liter (IU/L)
Standard Deviation 9.14
|
62.8 International units per liter (IU/L)
Standard Deviation 8.07
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 42
|
53.7 International units per liter (IU/L)
Standard Deviation 9.75
|
—
|
—
|
63.3 International units per liter (IU/L)
Standard Deviation 25.31
|
66.2 International units per liter (IU/L)
Standard Deviation 9.54
|
63.2 International units per liter (IU/L)
Standard Deviation 9.79
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 49
|
54.3 International units per liter (IU/L)
Standard Deviation 7.53
|
—
|
—
|
67.2 International units per liter (IU/L)
Standard Deviation 27.21
|
66.7 International units per liter (IU/L)
Standard Deviation 11.50
|
59.7 International units per liter (IU/L)
Standard Deviation 6.41
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Baseline (Day 1)
|
18.4 International units per liter (IU/L)
Standard Deviation 5.60
|
22.8 International units per liter (IU/L)
Standard Deviation 11.72
|
15.1 International units per liter (IU/L)
Standard Deviation 4.85
|
20.7 International units per liter (IU/L)
Standard Deviation 8.07
|
14.8 International units per liter (IU/L)
Standard Deviation 2.93
|
16.0 International units per liter (IU/L)
Standard Deviation 4.34
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 2
|
18.3 International units per liter (IU/L)
Standard Deviation 7.78
|
22.0 International units per liter (IU/L)
Standard Deviation 16.60
|
15.6 International units per liter (IU/L)
Standard Deviation 5.47
|
21.3 International units per liter (IU/L)
Standard Deviation 9.61
|
15.7 International units per liter (IU/L)
Standard Deviation 3.61
|
15.3 International units per liter (IU/L)
Standard Deviation 3.08
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 3
|
18.6 International units per liter (IU/L)
Standard Deviation 7.15
|
22.2 International units per liter (IU/L)
Standard Deviation 17.23
|
15.8 International units per liter (IU/L)
Standard Deviation 7.65
|
20.7 International units per liter (IU/L)
Standard Deviation 9.09
|
15.8 International units per liter (IU/L)
Standard Deviation 3.60
|
16.0 International units per liter (IU/L)
Standard Deviation 4.52
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 4
|
19.2 International units per liter (IU/L)
Standard Deviation 6.60
|
23.2 International units per liter (IU/L)
Standard Deviation 17.47
|
16.7 International units per liter (IU/L)
Standard Deviation 8.94
|
22.4 International units per liter (IU/L)
Standard Deviation 12.52
|
14.3 International units per liter (IU/L)
Standard Deviation 3.20
|
16.2 International units per liter (IU/L)
Standard Deviation 4.12
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 5
|
18.1 International units per liter (IU/L)
Standard Deviation 6.30
|
21.7 International units per liter (IU/L)
Standard Deviation 16.74
|
17.0 International units per liter (IU/L)
Standard Deviation 10.84
|
24.5 International units per liter (IU/L)
Standard Deviation 13.77
|
15.0 International units per liter (IU/L)
Standard Deviation 2.68
|
16.0 International units per liter (IU/L)
Standard Deviation 4.77
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 6
|
18.9 International units per liter (IU/L)
Standard Deviation 7.96
|
22.5 International units per liter (IU/L)
Standard Deviation 16.15
|
18.0 International units per liter (IU/L)
Standard Deviation 12.98
|
24.2 International units per liter (IU/L)
Standard Deviation 13.27
|
14.5 International units per liter (IU/L)
Standard Deviation 3.02
|
18.8 International units per liter (IU/L)
Standard Deviation 7.96
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 7
|
19.9 International units per liter (IU/L)
Standard Deviation 9.97
|
23.5 International units per liter (IU/L)
Standard Deviation 15.59
|
18.2 International units per liter (IU/L)
Standard Deviation 12.83
|
24.7 International units per liter (IU/L)
Standard Deviation 14.90
|
15.3 International units per liter (IU/L)
Standard Deviation 3.20
|
20.8 International units per liter (IU/L)
Standard Deviation 10.28
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 14
|
26.1 International units per liter (IU/L)
Standard Deviation 21.07
|
27.3 International units per liter (IU/L)
Standard Deviation 17.90
|
18.0 International units per liter (IU/L)
Standard Deviation 8.86
|
29.8 International units per liter (IU/L)
Standard Deviation 21.29
|
22.0 International units per liter (IU/L)
Standard Deviation 11.51
|
22.7 International units per liter (IU/L)
Standard Deviation 13.87
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 28
|
20.1 International units per liter (IU/L)
Standard Deviation 10.02
|
33.7 International units per liter (IU/L)
Standard Deviation 22.25
|
17.6 International units per liter (IU/L)
Standard Deviation 8.50
|
24.2 International units per liter (IU/L)
Standard Deviation 9.50
|
16.8 International units per liter (IU/L)
Standard Deviation 6.37
|
20.8 International units per liter (IU/L)
Standard Deviation 10.63
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 35
|
19.8 International units per liter (IU/L)
Standard Deviation 10.78
|
28.5 International units per liter (IU/L)
Standard Deviation 15.42
|
17.8 International units per liter (IU/L)
Standard Deviation 8.35
|
23.5 International units per liter (IU/L)
Standard Deviation 5.75
|
21.3 International units per liter (IU/L)
Standard Deviation 15.71
|
16.8 International units per liter (IU/L)
Standard Deviation 3.70
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Baseline (Day 1)
|
17.3 International units per liter (IU/L)
Standard Deviation 5.03
|
17.3 International units per liter (IU/L)
Standard Deviation 5.82
|
15.1 International units per liter (IU/L)
Standard Deviation 4.14
|
17.5 International units per liter (IU/L)
Standard Deviation 3.62
|
15.0 International units per liter (IU/L)
Standard Deviation 3.03
|
16.5 International units per liter (IU/L)
Standard Deviation 3.51
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 2
|
17.3 International units per liter (IU/L)
Standard Deviation 7.97
|
16.3 International units per liter (IU/L)
Standard Deviation 8.31
|
14.3 International units per liter (IU/L)
Standard Deviation 3.40
|
16.5 International units per liter (IU/L)
Standard Deviation 3.78
|
15.0 International units per liter (IU/L)
Standard Deviation 2.97
|
15.8 International units per liter (IU/L)
Standard Deviation 2.71
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 3
|
16.4 International units per liter (IU/L)
Standard Deviation 4.33
|
16.0 International units per liter (IU/L)
Standard Deviation 7.56
|
14.8 International units per liter (IU/L)
Standard Deviation 4.07
|
16.7 International units per liter (IU/L)
Standard Deviation 3.44
|
14.7 International units per liter (IU/L)
Standard Deviation 2.80
|
15.2 International units per liter (IU/L)
Standard Deviation 2.14
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 4
|
15.8 International units per liter (IU/L)
Standard Deviation 3.82
|
16.7 International units per liter (IU/L)
Standard Deviation 7.76
|
15.3 International units per liter (IU/L)
Standard Deviation 3.83
|
18.4 International units per liter (IU/L)
Standard Deviation 5.46
|
13.3 International units per liter (IU/L)
Standard Deviation 2.42
|
15.5 International units per liter (IU/L)
Standard Deviation 2.81
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 5
|
14.8 International units per liter (IU/L)
Standard Deviation 2.90
|
14.8 International units per liter (IU/L)
Standard Deviation 6.34
|
14.8 International units per liter (IU/L)
Standard Deviation 3.92
|
18.5 International units per liter (IU/L)
Standard Deviation 5.05
|
13.7 International units per liter (IU/L)
Standard Deviation 1.63
|
15.8 International units per liter (IU/L)
Standard Deviation 2.14
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 6
|
15.6 International units per liter (IU/L)
Standard Deviation 3.13
|
16.0 International units per liter (IU/L)
Standard Deviation 6.42
|
15.7 International units per liter (IU/L)
Standard Deviation 5.43
|
17.7 International units per liter (IU/L)
Standard Deviation 5.57
|
14.3 International units per liter (IU/L)
Standard Deviation 1.21
|
16.7 International units per liter (IU/L)
Standard Deviation 2.34
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 7
|
16.5 International units per liter (IU/L)
Standard Deviation 3.84
|
16.8 International units per liter (IU/L)
Standard Deviation 5.38
|
15.8 International units per liter (IU/L)
Standard Deviation 4.36
|
18.2 International units per liter (IU/L)
Standard Deviation 5.49
|
15.3 International units per liter (IU/L)
Standard Deviation 2.16
|
18.0 International units per liter (IU/L)
Standard Deviation 3.10
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 21
|
17.9 International units per liter (IU/L)
Standard Deviation 6.82
|
18.7 International units per liter (IU/L)
Standard Deviation 5.28
|
18.3 International units per liter (IU/L)
Standard Deviation 8.09
|
19.5 International units per liter (IU/L)
Standard Deviation 3.78
|
17.3 International units per liter (IU/L)
Standard Deviation 2.94
|
18.2 International units per liter (IU/L)
Standard Deviation 5.38
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 35
|
17.4 International units per liter (IU/L)
Standard Deviation 4.70
|
20.5 International units per liter (IU/L)
Standard Deviation 6.19
|
18.3 International units per liter (IU/L)
Standard Deviation 7.50
|
21.7 International units per liter (IU/L)
Standard Deviation 4.50
|
18.5 International units per liter (IU/L)
Standard Deviation 4.32
|
18.0 International units per liter (IU/L)
Standard Deviation 2.65
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 42
|
14.8 International units per liter (IU/L)
Standard Deviation 1.72
|
—
|
—
|
22.8 International units per liter (IU/L)
Standard Deviation 2.99
|
16.3 International units per liter (IU/L)
Standard Deviation 2.58
|
16.8 International units per liter (IU/L)
Standard Deviation 3.19
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 49
|
15.2 International units per liter (IU/L)
Standard Deviation 2.04
|
—
|
—
|
23.3 International units per liter (IU/L)
Standard Deviation 6.15
|
18.2 International units per liter (IU/L)
Standard Deviation 2.93
|
18.0 International units per liter (IU/L)
Standard Deviation 5.22
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 14
|
40.0 International units per liter (IU/L)
Standard Deviation 71.85
|
18.0 International units per liter (IU/L)
Standard Deviation 6.13
|
14.2 International units per liter (IU/L)
Standard Deviation 5.22
|
20.7 International units per liter (IU/L)
Standard Deviation 7.81
|
20.0 International units per liter (IU/L)
Standard Deviation 7.97
|
17.5 International units per liter (IU/L)
Standard Deviation 3.62
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST, Day 28
|
16.8 International units per liter (IU/L)
Standard Deviation 3.39
|
23.0 International units per liter (IU/L)
Standard Deviation 6.54
|
17.0 International units per liter (IU/L)
Standard Deviation 6.04
|
20.3 International units per liter (IU/L)
Standard Deviation 4.08
|
16.3 International units per liter (IU/L)
Standard Deviation 1.75
|
16.8 International units per liter (IU/L)
Standard Deviation 1.94
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, Day 2
|
48.6 International units per liter (IU/L)
Standard Deviation 7.52
|
59.0 International units per liter (IU/L)
Standard Deviation 10.86
|
60.4 International units per liter (IU/L)
Standard Deviation 23.56
|
63.5 International units per liter (IU/L)
Standard Deviation 21.68
|
58.2 International units per liter (IU/L)
Standard Deviation 10.61
|
54.5 International units per liter (IU/L)
Standard Deviation 9.73
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 21
|
23.4 International units per liter (IU/L)
Standard Deviation 15.94
|
23.5 International units per liter (IU/L)
Standard Deviation 13.98
|
20.2 International units per liter (IU/L)
Standard Deviation 10.61
|
24.5 International units per liter (IU/L)
Standard Deviation 10.54
|
19.2 International units per liter (IU/L)
Standard Deviation 7.41
|
22.2 International units per liter (IU/L)
Standard Deviation 15.66
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 42
|
14.2 International units per liter (IU/L)
Standard Deviation 3.60
|
—
|
—
|
25.5 International units per liter (IU/L)
Standard Deviation 6.02
|
16.3 International units per liter (IU/L)
Standard Deviation 4.23
|
17.5 International units per liter (IU/L)
Standard Deviation 4.76
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT, Day 49
|
15.0 International units per liter (IU/L)
Standard Deviation 4.34
|
—
|
—
|
27.8 International units per liter (IU/L)
Standard Deviation 9.85
|
18.7 International units per liter (IU/L)
Standard Deviation 10.23
|
17.2 International units per liter (IU/L)
Standard Deviation 5.23
|
PRIMARY outcome
Timeframe: Up to Day 63Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 2 (MAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they actually received. Only those participants with data available at specified time points were analyzed for the specific category titles.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. Standard Deviation (SD)=0.00000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.00000.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
2.2800 μmol/L
Standard Deviation 0.88304
|
2.8500 μmol/L
Standard Deviation 1.39621
|
2.1375 μmol/L
Standard Deviation 0.79158
|
1.7100 μmol/L
Standard Deviation 0.00000
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 2
|
2.1803 μmol/L
Standard Deviation 0.47090
|
3.1065 μmol/L
Standard Deviation 1.34826
|
—
|
2.1375 μmol/L
Standard Deviation 0.40103
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 3
|
2.2230 μmol/L
Standard Deviation 0.24183
|
—
|
2.1589 μmol/L
Standard Deviation 0.78595
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 5
|
2.0948 μmol/L
Standard Deviation 0.35253
|
3.1635 μmol/L
Standard Deviation 1.82498
|
—
|
2.1945 μmol/L
Standard Deviation 0.54524
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 6
|
2.2230 μmol/L
Standard Deviation 0.00000
|
—
|
2.3940 μmol/L
Standard Deviation 0.99289
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 7
|
1.8383 μmol/L
Standard Deviation 0.37917
|
2.9070 μmol/L
Standard Deviation 1.75056
|
—
|
2.5650 μmol/L
Standard Deviation 0.47141
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 11
|
2.2230 μmol/L
Standard Deviation 0.72549
|
2.6505 μmol/L
Standard Deviation 1.04948
|
—
|
2.4795 μmol/L
Standard Deviation 0.58989
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 12
|
1.9665 μmol/L
Standard Deviation 0.60458
|
—
|
2.5436 μmol/L
Standard Deviation 0.76712
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 14
|
1.5818 μmol/L
Standard Deviation 0.29204
|
2.6220 μmol/L
Standard Deviation 1.07426
|
—
|
1.9950 μmol/L
Standard Deviation 0.33625
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 21
|
1.7100 μmol/L
Standard Deviation 0.46307
|
2.7360 μmol/L
Standard Deviation 1.17978
|
—
|
2.5935 μmol/L
Standard Deviation 0.34905
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 22
|
3.5055 μmol/L
Standard Deviation 0.12092
|
—
|
3.2276 μmol/L
Standard Deviation 0.93409
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 28
|
1.5732 μmol/L
Standard Deviation 0.44262
|
2.0235 μmol/L
Standard Deviation 0.64362
|
2.0948 μmol/L
Standard Deviation 0.61145
|
1.8810 μmol/L
Standard Deviation 0.49561
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 35
|
1.7955 μmol/L
Standard Deviation 0.28098
|
1.8810 μmol/L
Standard Deviation 0.63982
|
2.1375 μmol/L
Standard Deviation 0.59937
|
1.7955 μmol/L
Standard Deviation 0.41536
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 42
|
2.0520 μmol/L
Standard Deviation 0.58241
|
2.0805 μmol/L
Standard Deviation 0.77549
|
2.0306 μmol/L
Standard Deviation 0.57401
|
1.5960 μmol/L
Standard Deviation 0.35322
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 49
|
2.1204 μmol/L
Standard Deviation 0.66887
|
2.2230 μmol/L
Standard Deviation 0.80206
|
2.2016 μmol/L
Standard Deviation 0.59544
|
1.9095 μmol/L
Standard Deviation 0.59646
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
11.9700 μmol/L
Standard Deviation 3.42000
|
15.1050 μmol/L
Standard Deviation 6.87553
|
9.6188 μmol/L
Standard Deviation 3.53265
|
8.2650 μmol/L
Standard Deviation 1.28724
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 2
|
10.6020 μmol/L
Standard Deviation 2.39807
|
17.9550 μmol/L
Standard Deviation 8.54521
|
—
|
11.6565 μmol/L
Standard Deviation 2.67858
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 3
|
16.3305 μmol/L
Standard Deviation 6.40851
|
—
|
12.2051 μmol/L
Standard Deviation 3.59151
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 11
|
9.4050 μmol/L
Standard Deviation 3.62746
|
15.2190 μmol/L
Standard Deviation 5.69715
|
—
|
13.0530 μmol/L
Standard Deviation 2.43917
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 12
|
11.4570 μmol/L
Standard Deviation 0.72549
|
—
|
15.6893 μmol/L
Standard Deviation 3.63062
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 14
|
7.3958 μmol/L
Standard Deviation 1.36354
|
14.2500 μmol/L
Standard Deviation 4.70504
|
—
|
13.9650 μmol/L
Standard Deviation 2.37109
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 15
|
15.5610 μmol/L
Standard Deviation 4.11112
|
—
|
14.9839 μmol/L
Standard Deviation 4.61559
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 35
|
9.2910 μmol/L
Standard Deviation 1.47365
|
10.7730 μmol/L
Standard Deviation 3.04361
|
10.3028 μmol/L
Standard Deviation 2.29739
|
9.1200 μmol/L
Standard Deviation 1.86591
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 42
|
10.6305 μmol/L
Standard Deviation 4.12024
|
10.7445 μmol/L
Standard Deviation 3.45304
|
10.2173 μmol/L
Standard Deviation 3.00208
|
8.8920 μmol/L
Standard Deviation 3.09505
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 49
|
11.5254 μmol/L
Standard Deviation 4.75214
|
12.1410 μmol/L
Standard Deviation 3.91885
|
11.1791 μmol/L
Standard Deviation 2.73896
|
9.7755 μmol/L
Standard Deviation 3.40872
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 56
|
10.1175 μmol/L
Standard Deviation 5.17248
|
11.0466 μmol/L
Standard Deviation 4.41233
|
8.3149 μmol/L
Standard Deviation 1.86413
|
8.8065 μmol/L
Standard Deviation 2.41770
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 63
|
8.9205 μmol/L
Standard Deviation 2.27993
|
10.3455 μmol/L
Standard Deviation 3.58815
|
8.9775 μmol/L
Standard Deviation 3.69817
|
10.1745 μmol/L
Standard Deviation 2.83829
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 8
|
2.3940 μmol/L
Standard Deviation 0.72549
|
—
|
2.4795 μmol/L
Standard Deviation 0.83272
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 15
|
2.7360 μmol/L
Standard Deviation 0.24183
|
—
|
2.8856 μmol/L
Standard Deviation 0.78329
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 56
|
1.9095 μmol/L
Standard Deviation 0.47656
|
2.2914 μmol/L
Standard Deviation 1.08555
|
1.8810 μmol/L
Standard Deviation 0.51706
|
1.7955 μmol/L
Standard Deviation 0.49265
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Direct Bilirubin, Day 63
|
1.7670 μmol/L
Standard Deviation 0.38491
|
1.9095 μmol/L
Standard Deviation 0.69601
|
1.8596 μmol/L
Standard Deviation 0.83990
|
1.9665 μmol/L
Standard Deviation 0.51584
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 5
|
10.6020 μmol/L
Standard Deviation 2.08498
|
18.8670 μmol/L
Standard Deviation 10.05775
|
—
|
13.0815 μmol/L
Standard Deviation 4.18409
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 6
|
15.1335 μmol/L
Standard Deviation 4.71570
|
—
|
13.2525 μmol/L
Standard Deviation 4.38546
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 7
|
9.0203 μmol/L
Standard Deviation 1.14604
|
16.5015 μmol/L
Standard Deviation 9.02436
|
—
|
14.8770 μmol/L
Standard Deviation 3.05894
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 8
|
16.5870 μmol/L
Standard Deviation 8.94773
|
—
|
14.4281 μmol/L
Standard Deviation 3.99249
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 21
|
7.6095 μmol/L
Standard Deviation 1.74666
|
15.8175 μmol/L
Standard Deviation 5.32110
|
—
|
14.9625 μmol/L
Standard Deviation 2.61076
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 22
|
19.9215 μmol/L
Standard Deviation 5.92485
|
—
|
18.0833 μmol/L
Standard Deviation 4.97435
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin and Total Bilirubin
Total Bilirubin, Day 28
|
8.3106 μmol/L
Standard Deviation 2.41710
|
10.3170 μmol/L
Standard Deviation 3.52221
|
9.7256 μmol/L
Standard Deviation 2.84298
|
9.7755 μmol/L
Standard Deviation 2.53499
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 63Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 2 (MAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they actually received. Only those participants with data available at specified time points were analyzed for the specific category titles.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALP, ALT and AST.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Baseline (Day 1)
|
66.2 IU/L
Standard Deviation 16.75
|
53.7 IU/L
Standard Deviation 10.01
|
57.5 IU/L
Standard Deviation 21.37
|
56.7 IU/L
Standard Deviation 11.41
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 2
|
69.0 IU/L
Standard Deviation 27.47
|
52.0 IU/L
Standard Deviation 8.97
|
—
|
56.2 IU/L
Standard Deviation 10.23
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 5
|
64.3 IU/L
Standard Deviation 23.14
|
49.8 IU/L
Standard Deviation 6.79
|
—
|
57.2 IU/L
Standard Deviation 9.60
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 6
|
64.0 IU/L
Standard Deviation 4.24
|
—
|
55.6 IU/L
Standard Deviation 19.78
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 7
|
64.8 IU/L
Standard Deviation 25.16
|
48.8 IU/L
Standard Deviation 7.39
|
—
|
56.5 IU/L
Standard Deviation 7.12
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 8
|
68.5 IU/L
Standard Deviation 9.19
|
—
|
55.8 IU/L
Standard Deviation 18.98
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 11
|
72.0 IU/L
Standard Deviation 2.83
|
47.5 IU/L
Standard Deviation 4.20
|
—
|
54.3 IU/L
Standard Deviation 11.47
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 28
|
61.4 IU/L
Standard Deviation 15.98
|
49.2 IU/L
Standard Deviation 11.69
|
59.8 IU/L
Standard Deviation 19.20
|
59.5 IU/L
Standard Deviation 10.73
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 35
|
64.2 IU/L
Standard Deviation 17.88
|
53.0 IU/L
Standard Deviation 15.26
|
59.9 IU/L
Standard Deviation 17.10
|
53.0 IU/L
Standard Deviation 11.56
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 42
|
67.7 IU/L
Standard Deviation 19.31
|
51.3 IU/L
Standard Deviation 11.76
|
62.1 IU/L
Standard Deviation 19.58
|
57.7 IU/L
Standard Deviation 12.09
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 49
|
64.2 IU/L
Standard Deviation 16.81
|
51.0 IU/L
Standard Deviation 12.36
|
58.8 IU/L
Standard Deviation 18.48
|
54.0 IU/L
Standard Deviation 12.71
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 56
|
69.0 IU/L
Standard Deviation 19.71
|
51.6 IU/L
Standard Deviation 11.15
|
62.8 IU/L
Standard Deviation 20.42
|
56.5 IU/L
Standard Deviation 7.20
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 63
|
66.5 IU/L
Standard Deviation 17.44
|
53.8 IU/L
Standard Deviation 11.75
|
58.8 IU/L
Standard Deviation 18.97
|
57.3 IU/L
Standard Deviation 11.08
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Baseline (Day 1)
|
18.7 IU/L
Standard Deviation 11.98
|
19.0 IU/L
Standard Deviation 6.93
|
16.3 IU/L
Standard Deviation 5.04
|
19.5 IU/L
Standard Deviation 7.69
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 2
|
16.0 IU/L
Standard Deviation 9.42
|
19.2 IU/L
Standard Deviation 5.12
|
—
|
19.8 IU/L
Standard Deviation 7.65
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 3
|
19.0 IU/L
Standard Deviation 8.49
|
—
|
18.3 IU/L
Standard Deviation 4.43
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 5
|
19.0 IU/L
Standard Deviation 8.76
|
19.5 IU/L
Standard Deviation 5.32
|
—
|
16.7 IU/L
Standard Deviation 6.28
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 6
|
15.0 IU/L
Standard Deviation 5.66
|
—
|
18.3 IU/L
Standard Deviation 5.26
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 7
|
22.3 IU/L
Standard Deviation 12.50
|
24.7 IU/L
Standard Deviation 9.14
|
—
|
16.5 IU/L
Standard Deviation 6.47
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 8
|
15.0 IU/L
Standard Deviation 7.07
|
—
|
16.8 IU/L
Standard Deviation 5.39
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 11
|
21.0 IU/L
Standard Deviation 11.31
|
20.8 IU/L
Standard Deviation 3.86
|
—
|
14.8 IU/L
Standard Deviation 5.34
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 14
|
33.3 IU/L
Standard Deviation 31.36
|
29.5 IU/L
Standard Deviation 14.01
|
—
|
16.7 IU/L
Standard Deviation 6.77
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 15
|
20.0 IU/L
Standard Deviation 7.07
|
—
|
21.5 IU/L
Standard Deviation 10.04
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 28
|
31.2 IU/L
Standard Deviation 28.37
|
27.5 IU/L
Standard Deviation 13.10
|
26.6 IU/L
Standard Deviation 8.02
|
33.7 IU/L
Standard Deviation 34.31
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 35
|
25.0 IU/L
Standard Deviation 12.76
|
36.8 IU/L
Standard Deviation 31.13
|
23.8 IU/L
Standard Deviation 6.45
|
22.8 IU/L
Standard Deviation 9.33
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 42
|
26.7 IU/L
Standard Deviation 20.29
|
27.8 IU/L
Standard Deviation 10.65
|
20.3 IU/L
Standard Deviation 8.36
|
21.2 IU/L
Standard Deviation 8.86
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 49
|
19.4 IU/L
Standard Deviation 12.76
|
24.2 IU/L
Standard Deviation 12.19
|
18.5 IU/L
Standard Deviation 7.41
|
17.0 IU/L
Standard Deviation 6.10
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 56
|
19.0 IU/L
Standard Deviation 9.49
|
21.2 IU/L
Standard Deviation 11.45
|
18.0 IU/L
Standard Deviation 6.14
|
14.7 IU/L
Standard Deviation 5.50
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 63
|
15.2 IU/L
Standard Deviation 5.85
|
19.3 IU/L
Standard Deviation 7.69
|
18.4 IU/L
Standard Deviation 7.71
|
15.2 IU/L
Standard Deviation 2.64
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Baseline (Day 1)
|
16.2 IU/L
Standard Deviation 2.99
|
19.2 IU/L
Standard Deviation 4.12
|
14.9 IU/L
Standard Deviation 3.14
|
17.8 IU/L
Standard Deviation 3.54
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 2
|
14.8 IU/L
Standard Deviation 2.06
|
17.2 IU/L
Standard Deviation 2.64
|
—
|
17.5 IU/L
Standard Deviation 3.99
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 3
|
15.5 IU/L
Standard Deviation 3.54
|
—
|
16.3 IU/L
Standard Deviation 2.25
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 5
|
18.8 IU/L
Standard Deviation 3.69
|
18.5 IU/L
Standard Deviation 4.14
|
—
|
15.7 IU/L
Standard Deviation 2.94
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 6
|
15.0 IU/L
Standard Deviation 1.41
|
—
|
15.3 IU/L
Standard Deviation 3.01
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 7
|
19.8 IU/L
Standard Deviation 6.40
|
24.5 IU/L
Standard Deviation 10.88
|
—
|
16.0 IU/L
Standard Deviation 2.83
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 8
|
15.0 IU/L
Standard Deviation 2.83
|
—
|
15.5 IU/L
Standard Deviation 2.14
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 11
|
17.0 IU/L
Standard Deviation 2.83
|
19.5 IU/L
Standard Deviation 3.11
|
—
|
13.8 IU/L
Standard Deviation 1.94
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 12
|
16.5 IU/L
Standard Deviation 2.12
|
—
|
16.3 IU/L
Standard Deviation 3.33
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 14
|
24.8 IU/L
Standard Deviation 17.50
|
22.8 IU/L
Standard Deviation 6.55
|
—
|
15.7 IU/L
Standard Deviation 2.73
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 15
|
16.0 IU/L
Standard Deviation 2.83
|
—
|
16.0 IU/L
Standard Deviation 3.59
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 21
|
17.0 IU/L
Standard Deviation 3.83
|
23.3 IU/L
Standard Deviation 5.79
|
—
|
18.8 IU/L
Standard Deviation 4.26
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 22
|
17.5 IU/L
Standard Deviation 2.12
|
—
|
17.9 IU/L
Standard Deviation 2.47
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 28
|
23.6 IU/L
Standard Deviation 12.20
|
21.5 IU/L
Standard Deviation 5.13
|
21.9 IU/L
Standard Deviation 18.76
|
49.5 IU/L
Standard Deviation 80.64
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 49
|
18.2 IU/L
Standard Deviation 4.97
|
19.5 IU/L
Standard Deviation 5.28
|
16.1 IU/L
Standard Deviation 5.41
|
16.5 IU/L
Standard Deviation 1.97
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 63
|
15.2 IU/L
Standard Deviation 1.72
|
19.8 IU/L
Standard Deviation 6.34
|
16.1 IU/L
Standard Deviation 3.72
|
17.0 IU/L
Standard Deviation 3.41
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 3
|
68.0 IU/L
Standard Deviation 5.66
|
—
|
58.4 IU/L
Standard Deviation 20.88
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 12
|
71.0 IU/L
Standard Deviation 4.24
|
—
|
58.3 IU/L
Standard Deviation 21.97
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 14
|
69.5 IU/L
Standard Deviation 24.52
|
47.7 IU/L
Standard Deviation 7.53
|
—
|
58.0 IU/L
Standard Deviation 12.20
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 15
|
66.0 IU/L
Standard Deviation 5.66
|
—
|
58.0 IU/L
Standard Deviation 19.09
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 21
|
62.0 IU/L
Standard Deviation 19.41
|
50.5 IU/L
Standard Deviation 5.21
|
—
|
57.5 IU/L
Standard Deviation 11.64
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 22
|
70.5 IU/L
Standard Deviation 4.95
|
—
|
62.6 IU/L
Standard Deviation 19.53
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 12
|
19.0 IU/L
Standard Deviation 8.49
|
—
|
19.1 IU/L
Standard Deviation 8.81
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 21
|
24.5 IU/L
Standard Deviation 11.39
|
32.8 IU/L
Standard Deviation 15.35
|
—
|
23.2 IU/L
Standard Deviation 9.28
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 22
|
21.5 IU/L
Standard Deviation 3.54
|
—
|
24.1 IU/L
Standard Deviation 8.46
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 35
|
20.0 IU/L
Standard Deviation 5.51
|
24.7 IU/L
Standard Deviation 10.03
|
19.5 IU/L
Standard Deviation 6.63
|
18.8 IU/L
Standard Deviation 5.19
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 42
|
21.5 IU/L
Standard Deviation 10.29
|
22.3 IU/L
Standard Deviation 2.66
|
15.9 IU/L
Standard Deviation 2.95
|
18.0 IU/L
Standard Deviation 3.35
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 56
|
18.0 IU/L
Standard Deviation 3.63
|
20.8 IU/L
Standard Deviation 4.09
|
16.9 IU/L
Standard Deviation 6.17
|
16.5 IU/L
Standard Deviation 2.17
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 3 (Single Dose) who received 1 single dose of study treatment. The participants were analyzed according to the treatment they actually received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
1.9950 μmol/L
Standard Deviation 0.69810
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
2.3085 μmol/L
Standard Deviation 0.68186
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
2.2515 μmol/L
Standard Deviation 0.59646
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 4
|
2.1660 μmol/L
Standard Deviation 0.66375
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
2.2800 μmol/L
Standard Deviation 0.55848
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
1.7670 μmol/L
Standard Deviation 0.69810
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
1.7385 μmol/L
Standard Deviation 0.77549
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
1.9380 μmol/L
Standard Deviation 1.02979
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
1.8525 μmol/L
Standard Deviation 0.79043
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 35
|
1.8525 μmol/L
Standard Deviation 0.72077
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 42
|
1.9494 μmol/L
Standard Deviation 0.56196
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 49
|
1.6530 μmol/L
Standard Deviation 0.39981
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
8.8920 μmol/L
Standard Deviation 4.03357
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 35
|
10.0890 μmol/L
Standard Deviation 5.11859
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 42
|
8.8920 μmol/L
Standard Deviation 2.25240
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 49
|
8.4645 μmol/L
Standard Deviation 2.29866
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
1.9380 μmol/L
Standard Deviation 0.57905
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
9.9750 μmol/L
Standard Deviation 4.24640
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
12.2550 μmol/L
Standard Deviation 4.31200
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
11.0580 μmol/L
Standard Deviation 3.23487
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 4
|
10.4025 μmol/L
Standard Deviation 2.63898
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
10.7730 μmol/L
Standard Deviation 3.30875
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
11.3715 μmol/L
Standard Deviation 2.69888
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
8.8635 μmol/L
Standard Deviation 3.39669
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
8.7780 μmol/L
Standard Deviation 5.31551
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
9.0915 μmol/L
Standard Deviation 5.22647
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 3 (Single Dose) who received 1 single dose of study treatment. The participants were analyzed according to the treatment they actually received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALP, ALT and AST.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 7
|
50.3 IU/L
Standard Deviation 9.29
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 14
|
60.2 IU/L
Standard Deviation 18.27
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 21
|
58.0 IU/L
Standard Deviation 15.47
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 28
|
59.7 IU/L
Standard Deviation 18.99
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 35
|
59.5 IU/L
Standard Deviation 16.43
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 42
|
58.2 IU/L
Standard Deviation 8.81
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 49
|
55.8 IU/L
Standard Deviation 13.39
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Baseline (Day 1)
|
24.3 IU/L
Standard Deviation 17.07
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 2
|
19.2 IU/L
Standard Deviation 13.04
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 3
|
19.2 IU/L
Standard Deviation 11.00
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 6
|
17.5 IU/L
Standard Deviation 4.68
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 7
|
17.2 IU/L
Standard Deviation 5.23
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 14
|
24.3 IU/L
Standard Deviation 19.58
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 21
|
20.0 IU/L
Standard Deviation 7.97
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 28
|
24.5 IU/L
Standard Deviation 16.72
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 35
|
21.2 IU/L
Standard Deviation 7.91
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 42
|
28.2 IU/L
Standard Deviation 27.31
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 49
|
19.5 IU/L
Standard Deviation 9.71
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Baseline (Day 1)
|
55.7 IU/L
Standard Deviation 11.78
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 2
|
47.8 IU/L
Standard Deviation 10.76
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 3
|
50.2 IU/L
Standard Deviation 10.63
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 4
|
50.8 IU/L
Standard Deviation 9.68
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 5
|
48.8 IU/L
Standard Deviation 7.94
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALP, Day 6
|
49.7 IU/L
Standard Deviation 10.84
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 4
|
19.2 IU/L
Standard Deviation 8.80
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 5
|
18.7 IU/L
Standard Deviation 8.36
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 6
|
20.3 IU/L
Standard Deviation 9.20
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 7
|
21.3 IU/L
Standard Deviation 10.78
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 14
|
44.7 IU/L
Standard Deviation 64.91
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 21
|
31.3 IU/L
Standard Deviation 34.51
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 28
|
41.8 IU/L
Standard Deviation 57.78
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 35
|
26.7 IU/L
Standard Deviation 22.90
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 42
|
34.6 IU/L
Standard Deviation 47.24
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
ALT, Day 49
|
26.3 IU/L
Standard Deviation 30.80
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Baseline (Day 1)
|
17.5 IU/L
Standard Deviation 4.28
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 2
|
15.2 IU/L
Standard Deviation 3.49
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 3
|
15.2 IU/L
Standard Deviation 3.37
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 4
|
15.7 IU/L
Standard Deviation 2.42
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALP, ALT and AST
AST, Day 5
|
15.3 IU/L
Standard Deviation 2.80
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received 1 full dose of study treatment. The participants were analyzed according to the treatment they actually received. Only those participants with data available at specified time points were analyzed for the specific category titles.
Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. Standard Deviation (SD)=0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=10 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
-0.2052 μmol/L
Standard Deviation 1.04109
|
-0.2850 μmol/L
Standard Deviation 0.69810
|
-1.1628 μmol/L
Standard Deviation 1.04995
|
-0.6555 μmol/L
Standard Deviation 0.68755
|
0.1710 μmol/L
Standard Deviation 0.72549
|
-0.1710 μmol/L
Standard Deviation 1.72023
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
-0.0342 μmol/L
Standard Deviation 1.03168
|
0.1425 μmol/L
Standard Deviation 0.80509
|
-0.5415 μmol/L
Standard Deviation 0.86125
|
-0.8550 μmol/L
Standard Deviation 0.93034
|
0.1995 μmol/L
Standard Deviation 0.55586
|
-0.7980 μmol/L
Standard Deviation 0.76218
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
2.5650 μmol/L
Standard Deviation 1.20915
|
1.9950 μmol/L
Standard Deviation 0.69810
|
2.9314 μmol/L
Standard Deviation 0.83439
|
2.2800 μmol/L
Standard Deviation 1.39621
|
2.2800 μmol/L
Standard Deviation 0.88304
|
2.8500 μmol/L
Standard Deviation 0.88304
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
0.0570 μmol/L
Standard Deviation 0.80206
|
0.5130 μmol/L
Standard Deviation 0.47141
|
0.0244 μmol/L
Standard Deviation 0.96948
|
-0.2280 μmol/L
Standard Deviation 0.46726
|
0.4560 μmol/L
Standard Deviation 0.69810
|
0.2280 μmol/L
Standard Deviation 1.00100
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 4
|
-0.0684 μmol/L
Standard Deviation 1.09107
|
0.0285 μmol/L
Standard Deviation 0.39614
|
-0.1140 μmol/L
Standard Deviation 0.69810
|
-0.4104 μmol/L
Standard Deviation 0.84295
|
-0.0285 μmol/L
Standard Deviation 0.65264
|
-0.1710 μmol/L
Standard Deviation 0.85841
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
0.0000 μmol/L
Standard Deviation 1.01004
|
0.6555 μmol/L
Standard Deviation 0.45134
|
-0.5415 μmol/L
Standard Deviation 0.45134
|
-0.4845 μmol/L
Standard Deviation 0.54524
|
0.0855 μmol/L
Standard Deviation 0.87695
|
0.0285 μmol/L
Standard Deviation 0.95158
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
0.3249 μmol/L
Standard Deviation 1.18869
|
0.4845 μmol/L
Standard Deviation 0.60619
|
-0.5700 μmol/L
Standard Deviation 0.70643
|
-0.3705 μmol/L
Standard Deviation 0.67033
|
0.0570 μmol/L
Standard Deviation 0.66375
|
-0.2565 μmol/L
Standard Deviation 0.69880
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 35
|
-0.2052 μmol/L
Standard Deviation 1.10174
|
0.1140 μmol/L
Standard Deviation 0.27924
|
-0.5700 μmol/L
Standard Deviation 0.84928
|
-0.5415 μmol/L
Standard Deviation 1.02267
|
0.0000 μmol/L
Standard Deviation 0.76474
|
-0.7866 μmol/L
Standard Deviation 0.67971
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 49
|
0.0855 μmol/L
Standard Deviation 1.19333
|
—
|
—
|
-0.7125 μmol/L
Standard Deviation 0.96379
|
0.3705 μmol/L
Standard Deviation 0.84756
|
-0.1995 μmol/L
Standard Deviation 0.95770
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
13.1670 μmol/L
Standard Deviation 6.84237
|
12.5400 μmol/L
Standard Deviation 3.84908
|
14.9014 μmol/L
Standard Deviation 3.65613
|
12.2550 μmol/L
Standard Deviation 8.47558
|
11.6850 μmol/L
Standard Deviation 5.00498
|
10.8300 μmol/L
Standard Deviation 5.26132
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
1.5770 μmol/L
Standard Deviation 4.50462
|
-0.6270 μmol/L
Standard Deviation 1.14285
|
-1.4657 μmol/L
Standard Deviation 2.08465
|
-1.4820 μmol/L
Standard Deviation 1.96662
|
6.2985 μmol/L
Standard Deviation 3.89252
|
5.4435 μmol/L
Standard Deviation 4.21426
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
1.1286 μmol/L
Standard Deviation 4.54801
|
-0.7695 μmol/L
Standard Deviation 1.10159
|
-2.9640 μmol/L
Standard Deviation 1.07426
|
-1.7955 μmol/L
Standard Deviation 1.66407
|
3.8190 μmol/L
Standard Deviation 4.03164
|
4.7595 μmol/L
Standard Deviation 4.71342
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 4
|
0.4617 μmol/L
Standard Deviation 5.19048
|
-3.0780 μmol/L
Standard Deviation 1.47100
|
-0.8835 μmol/L
Standard Deviation 3.77816
|
-1.6416 μmol/L
Standard Deviation 2.98785
|
4.1610 μmol/L
Standard Deviation 2.59033
|
2.5650 μmol/L
Standard Deviation 3.61332
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
0.3933 μmol/L
Standard Deviation 5.87628
|
-0.8835 μmol/L
Standard Deviation 0.97585
|
-3.2775 μmol/L
Standard Deviation 4.31980
|
-1.5675 μmol/L
Standard Deviation 2.78350
|
4.0470 μmol/L
Standard Deviation 3.19851
|
3.9045 μmol/L
Standard Deviation 2.63233
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
-0.2052 μmol/L
Standard Deviation 6.38797
|
-0.4275 μmol/L
Standard Deviation 0.98973
|
-5.4720 μmol/L
Standard Deviation 3.74330
|
-2.9070 μmol/L
Standard Deviation 2.84087
|
2.2515 μmol/L
Standard Deviation 4.45049
|
3.5340 μmol/L
Standard Deviation 2.75234
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
0.6840 μmol/L
Standard Deviation 5.49629
|
-1.9380 μmol/L
Standard Deviation 1.87841
|
-5.1585 μmol/L
Standard Deviation 3.43777
|
-1.5390 μmol/L
Standard Deviation 2.91002
|
4.9875 μmol/L
Standard Deviation 4.06738
|
1.7100 μmol/L
Standard Deviation 3.37351
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
-2.7531 μmol/L
Standard Deviation 6.09471
|
-5.7855 μmol/L
Standard Deviation 1.36978
|
-6.7374 μmol/L
Standard Deviation 3.07705
|
-4.3035 μmol/L
Standard Deviation 5.00001
|
1.1970 μmol/L
Standard Deviation 2.11861
|
0.9690 μmol/L
Standard Deviation 7.12039
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
-0.7353 μmol/L
Standard Deviation 3.99004
|
-2.9355 μmol/L
Standard Deviation 2.88664
|
-4.8165 μmol/L
Standard Deviation 3.47667
|
-4.7025 μmol/L
Standard Deviation 5.15927
|
0.7980 μmol/L
Standard Deviation 2.90532
|
-1.9095 μmol/L
Standard Deviation 4.55440
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
0.0000 μmol/L
Standard Deviation 4.73683
|
-3.4200 μmol/L
Standard Deviation 1.69626
|
-3.8304 μmol/L
Standard Deviation 2.83984
|
-4.2750 μmol/L
Standard Deviation 5.88995
|
5.0730 μmol/L
Standard Deviation 5.72446
|
0.5700 μmol/L
Standard Deviation 6.01635
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 35
|
-1.1628 μmol/L
Standard Deviation 4.21939
|
-3.9615 μmol/L
Standard Deviation 1.41183
|
-5.0445 μmol/L
Standard Deviation 4.68272
|
-3.8190 μmol/L
Standard Deviation 5.34403
|
-0.3135 μmol/L
Standard Deviation 3.91200
|
-2.1888 μmol/L
Standard Deviation 4.84024
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 42
|
0.0285 μmol/L
Standard Deviation 5.67701
|
—
|
—
|
-4.0470 μmol/L
Standard Deviation 4.70877
|
3.9045 μmol/L
Standard Deviation 5.91316
|
2.1375 μmol/L
Standard Deviation 2.03985
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
0.1368 μmol/L
Standard Deviation 0.87861
|
0.4845 μmol/L
Standard Deviation 0.47656
|
-0.1425 μmol/L
Standard Deviation 0.62518
|
-0.4275 μmol/L
Standard Deviation 0.51584
|
0.0855 μmol/L
Standard Deviation 0.57989
|
0.1995 μmol/L
Standard Deviation 0.96379
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
0.1710 μmol/L
Standard Deviation 1.19564
|
0.6555 μmol/L
Standard Deviation 0.36542
|
-0.3420 μmol/L
Standard Deviation 0.83072
|
-0.3135 μmol/L
Standard Deviation 0.62518
|
0.5415 μmol/L
Standard Deviation 0.42464
|
-0.0285 μmol/L
Standard Deviation 0.58657
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
0.2565 μmol/L
Standard Deviation 1.37570
|
0.0855 μmol/L
Standard Deviation 0.63753
|
-0.4104 μmol/L
Standard Deviation 0.44591
|
-0.6270 μmol/L
Standard Deviation 0.98331
|
0.9690 μmol/L
Standard Deviation 0.60859
|
-0.5130 μmol/L
Standard Deviation 1.23310
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 42
|
0.0855 μmol/L
Standard Deviation 1.41321
|
—
|
—
|
-0.6270 μmol/L
Standard Deviation 0.84928
|
0.4560 μmol/L
Standard Deviation 0.97134
|
-0.0855 μmol/L
Standard Deviation 0.77045
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 49
|
-0.7695 μmol/L
Standard Deviation 4.69270
|
—
|
—
|
-3.4200 μmol/L
Standard Deviation 4.88354
|
3.1350 μmol/L
Standard Deviation 2.76717
|
1.9380 μmol/L
Standard Deviation 8.15487
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received 1 full dose of study treatment. The participants were analyzed according to the treatment they actually received. Only those participants with data available at specified time points were analyzed for the specific category titles.
Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=10 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 3
|
-3.6 IU/L
Standard Deviation 5.97
|
-5.8 IU/L
Standard Deviation 3.97
|
-9.5 IU/L
Standard Deviation 9.54
|
-6.0 IU/L
Standard Deviation 6.20
|
-8.2 IU/L
Standard Deviation 4.36
|
-9.3 IU/L
Standard Deviation 6.47
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 4
|
-2.5 IU/L
Standard Deviation 6.19
|
-4.2 IU/L
Standard Deviation 4.92
|
-5.2 IU/L
Standard Deviation 12.46
|
-5.4 IU/L
Standard Deviation 7.30
|
-0.8 IU/L
Standard Deviation 2.86
|
-9.0 IU/L
Standard Deviation 5.06
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 7
|
-0.1 IU/L
Standard Deviation 6.95
|
-0.3 IU/L
Standard Deviation 5.79
|
-4.0 IU/L
Standard Deviation 14.86
|
-4.7 IU/L
Standard Deviation 5.50
|
2.3 IU/L
Standard Deviation 4.23
|
-5.0 IU/L
Standard Deviation 9.49
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 21
|
1.2 IU/L
Standard Deviation 3.49
|
-6.0 IU/L
Standard Deviation 2.28
|
-3.5 IU/L
Standard Deviation 6.80
|
-3.0 IU/L
Standard Deviation 9.55
|
-2.5 IU/L
Standard Deviation 4.59
|
-2.7 IU/L
Standard Deviation 10.01
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 28
|
2.1 IU/L
Standard Deviation 7.29
|
-7.2 IU/L
Standard Deviation 7.33
|
-0.2 IU/L
Standard Deviation 12.72
|
-3.5 IU/L
Standard Deviation 5.89
|
-0.5 IU/L
Standard Deviation 4.51
|
3.7 IU/L
Standard Deviation 17.44
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 35
|
1.1 IU/L
Standard Deviation 4.07
|
1.7 IU/L
Standard Deviation 5.54
|
-3.3 IU/L
Standard Deviation 6.83
|
-5.2 IU/L
Standard Deviation 7.11
|
0.7 IU/L
Standard Deviation 7.20
|
-0.6 IU/L
Standard Deviation 9.07
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 42
|
-1.8 IU/L
Standard Deviation 5.78
|
—
|
—
|
-5.7 IU/L
Standard Deviation 3.67
|
2.2 IU/L
Standard Deviation 6.74
|
1.3 IU/L
Standard Deviation 6.44
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Baseline (Day 1)
|
18.4 IU/L
Standard Deviation 5.60
|
22.8 IU/L
Standard Deviation 11.72
|
15.1 IU/L
Standard Deviation 4.85
|
20.7 IU/L
Standard Deviation 8.07
|
14.8 IU/L
Standard Deviation 2.93
|
16.0 IU/L
Standard Deviation 4.34
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 2
|
-0.1 IU/L
Standard Deviation 4.81
|
-0.8 IU/L
Standard Deviation 5.64
|
0.4 IU/L
Standard Deviation 4.28
|
0.7 IU/L
Standard Deviation 1.75
|
0.8 IU/L
Standard Deviation 3.66
|
-0.7 IU/L
Standard Deviation 1.86
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 3
|
0.2 IU/L
Standard Deviation 6.34
|
-0.7 IU/L
Standard Deviation 6.44
|
1.5 IU/L
Standard Deviation 6.09
|
0.0 IU/L
Standard Deviation 1.26
|
1.0 IU/L
Standard Deviation 3.79
|
0.0 IU/L
Standard Deviation 1.79
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 4
|
0.8 IU/L
Standard Deviation 7.13
|
0.3 IU/L
Standard Deviation 6.38
|
2.3 IU/L
Standard Deviation 7.37
|
2.6 IU/L
Standard Deviation 3.85
|
-0.5 IU/L
Standard Deviation 3.73
|
0.2 IU/L
Standard Deviation 2.14
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 5
|
-0.3 IU/L
Standard Deviation 7.97
|
-1.2 IU/L
Standard Deviation 6.18
|
2.7 IU/L
Standard Deviation 9.37
|
3.8 IU/L
Standard Deviation 6.43
|
0.2 IU/L
Standard Deviation 2.93
|
0.0 IU/L
Standard Deviation 2.83
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 6
|
0.5 IU/L
Standard Deviation 9.57
|
-0.3 IU/L
Standard Deviation 5.85
|
3.7 IU/L
Standard Deviation 11.29
|
3.5 IU/L
Standard Deviation 6.72
|
-0.3 IU/L
Standard Deviation 3.98
|
2.8 IU/L
Standard Deviation 4.96
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 7
|
1.5 IU/L
Standard Deviation 11.65
|
0.7 IU/L
Standard Deviation 5.61
|
3.8 IU/L
Standard Deviation 10.87
|
4.0 IU/L
Standard Deviation 7.97
|
0.5 IU/L
Standard Deviation 4.51
|
4.8 IU/L
Standard Deviation 7.03
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 14
|
7.7 IU/L
Standard Deviation 16.96
|
4.5 IU/L
Standard Deviation 11.26
|
5.2 IU/L
Standard Deviation 6.72
|
9.2 IU/L
Standard Deviation 14.58
|
6.2 IU/L
Standard Deviation 11.63
|
6.7 IU/L
Standard Deviation 10.03
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 21
|
5.0 IU/L
Standard Deviation 14.54
|
0.7 IU/L
Standard Deviation 4.76
|
5.8 IU/L
Standard Deviation 8.42
|
3.8 IU/L
Standard Deviation 4.54
|
4.3 IU/L
Standard Deviation 5.16
|
6.2 IU/L
Standard Deviation 11.63
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 28
|
1.7 IU/L
Standard Deviation 10.22
|
10.8 IU/L
Standard Deviation 20.21
|
4.8 IU/L
Standard Deviation 5.63
|
3.5 IU/L
Standard Deviation 4.09
|
2.0 IU/L
Standard Deviation 4.34
|
4.8 IU/L
Standard Deviation 6.88
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 35
|
1.4 IU/L
Standard Deviation 9.88
|
5.7 IU/L
Standard Deviation 9.54
|
3.5 IU/L
Standard Deviation 4.76
|
2.8 IU/L
Standard Deviation 5.49
|
6.5 IU/L
Standard Deviation 15.36
|
2.4 IU/L
Standard Deviation 2.41
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 42
|
-1.7 IU/L
Standard Deviation 3.78
|
—
|
—
|
4.8 IU/L
Standard Deviation 7.70
|
1.5 IU/L
Standard Deviation 3.62
|
1.5 IU/L
Standard Deviation 2.74
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 49
|
-0.8 IU/L
Standard Deviation 2.64
|
—
|
—
|
7.2 IU/L
Standard Deviation 8.50
|
3.8 IU/L
Standard Deviation 9.75
|
1.2 IU/L
Standard Deviation 4.22
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Baseline (Day 1)
|
17.3 IU/L
Standard Deviation 5.03
|
17.3 IU/L
Standard Deviation 5.82
|
15.1 IU/L
Standard Deviation 4.14
|
17.5 IU/L
Standard Deviation 3.62
|
15.0 IU/L
Standard Deviation 3.03
|
16.5 IU/L
Standard Deviation 3.51
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 2
|
-0.1 IU/L
Standard Deviation 3.69
|
-1.0 IU/L
Standard Deviation 3.10
|
-0.9 IU/L
Standard Deviation 4.34
|
-1.0 IU/L
Standard Deviation 0.89
|
0.0 IU/L
Standard Deviation 3.29
|
-0.7 IU/L
Standard Deviation 1.51
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 3
|
-0.9 IU/L
Standard Deviation 3.25
|
-1.3 IU/L
Standard Deviation 2.94
|
1.0 IU/L
Standard Deviation 3.69
|
-0.8 IU/L
Standard Deviation 2.23
|
-0.3 IU/L
Standard Deviation 2.50
|
-1.3 IU/L
Standard Deviation 2.42
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 4
|
-1.5 IU/L
Standard Deviation 3.95
|
-0.7 IU/L
Standard Deviation 3.01
|
1.5 IU/L
Standard Deviation 2.81
|
1.0 IU/L
Standard Deviation 2.83
|
-1.7 IU/L
Standard Deviation 2.07
|
-1.0 IU/L
Standard Deviation 3.22
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 5
|
-2.5 IU/L
Standard Deviation 4.48
|
-2.5 IU/L
Standard Deviation 2.43
|
1.0 IU/L
Standard Deviation 3.22
|
1.0 IU/L
Standard Deviation 2.83
|
-1.3 IU/L
Standard Deviation 2.07
|
-0.7 IU/L
Standard Deviation 2.34
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 6
|
-1.7 IU/L
Standard Deviation 5.12
|
-1.3 IU/L
Standard Deviation 2.34
|
1.8 IU/L
Standard Deviation 4.92
|
0.2 IU/L
Standard Deviation 4.17
|
-0.7 IU/L
Standard Deviation 2.50
|
0.2 IU/L
Standard Deviation 3.54
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 7
|
-0.8 IU/L
Standard Deviation 5.87
|
-0.5 IU/L
Standard Deviation 2.95
|
2.0 IU/L
Standard Deviation 3.22
|
0.7 IU/L
Standard Deviation 2.73
|
0.3 IU/L
Standard Deviation 1.63
|
1.5 IU/L
Standard Deviation 4.23
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 14
|
22.7 IU/L
Standard Deviation 70.63
|
0.7 IU/L
Standard Deviation 3.50
|
0.6 IU/L
Standard Deviation 3.05
|
3.2 IU/L
Standard Deviation 5.12
|
4.6 IU/L
Standard Deviation 6.11
|
1.0 IU/L
Standard Deviation 1.79
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 21
|
0.6 IU/L
Standard Deviation 7.37
|
1.3 IU/L
Standard Deviation 1.75
|
4.5 IU/L
Standard Deviation 6.35
|
2.0 IU/L
Standard Deviation 3.63
|
2.3 IU/L
Standard Deviation 3.01
|
1.7 IU/L
Standard Deviation 7.20
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 28
|
-0.5 IU/L
Standard Deviation 4.88
|
5.7 IU/L
Standard Deviation 6.56
|
3.4 IU/L
Standard Deviation 3.97
|
2.8 IU/L
Standard Deviation 3.31
|
1.3 IU/L
Standard Deviation 3.27
|
0.3 IU/L
Standard Deviation 4.68
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 35
|
0.1 IU/L
Standard Deviation 2.96
|
3.2 IU/L
Standard Deviation 5.31
|
4.5 IU/L
Standard Deviation 5.58
|
4.2 IU/L
Standard Deviation 5.34
|
3.5 IU/L
Standard Deviation 6.57
|
1.0 IU/L
Standard Deviation 1.58
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 42
|
-1.0 IU/L
Standard Deviation 2.53
|
—
|
—
|
5.3 IU/L
Standard Deviation 4.72
|
1.3 IU/L
Standard Deviation 1.37
|
0.3 IU/L
Standard Deviation 3.61
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 49
|
-0.7 IU/L
Standard Deviation 1.75
|
—
|
—
|
5.8 IU/L
Standard Deviation 4.07
|
3.2 IU/L
Standard Deviation 4.71
|
1.5 IU/L
Standard Deviation 5.82
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Baseline (Day 1)
|
51.8 IU/L
Standard Deviation 9.39
|
64.7 IU/L
Standard Deviation 10.88
|
67.1 IU/L
Standard Deviation 27.91
|
69.0 IU/L
Standard Deviation 25.04
|
64.0 IU/L
Standard Deviation 11.10
|
61.8 IU/L
Standard Deviation 15.41
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 2
|
-4.2 IU/L
Standard Deviation 5.74
|
-5.7 IU/L
Standard Deviation 2.88
|
-6.7 IU/L
Standard Deviation 5.53
|
-5.5 IU/L
Standard Deviation 5.09
|
-5.8 IU/L
Standard Deviation 3.97
|
-7.3 IU/L
Standard Deviation 7.23
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 5
|
-3.7 IU/L
Standard Deviation 3.47
|
-5.5 IU/L
Standard Deviation 4.42
|
-11.0 IU/L
Standard Deviation 10.33
|
-5.7 IU/L
Standard Deviation 8.04
|
-3.5 IU/L
Standard Deviation 3.62
|
-4.2 IU/L
Standard Deviation 9.20
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 6
|
-3.0 IU/L
Standard Deviation 4.92
|
-2.2 IU/L
Standard Deviation 3.66
|
-9.3 IU/L
Standard Deviation 11.66
|
-6.0 IU/L
Standard Deviation 6.63
|
-1.7 IU/L
Standard Deviation 2.80
|
-7.3 IU/L
Standard Deviation 10.56
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 14
|
3.0 IU/L
Standard Deviation 5.96
|
-2.5 IU/L
Standard Deviation 5.61
|
-6.8 IU/L
Standard Deviation 15.22
|
-4.0 IU/L
Standard Deviation 5.18
|
2.0 IU/L
Standard Deviation 7.04
|
-0.5 IU/L
Standard Deviation 8.29
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 49
|
-1.2 IU/L
Standard Deviation 4.45
|
—
|
—
|
-1.8 IU/L
Standard Deviation 5.85
|
2.7 IU/L
Standard Deviation 9.35
|
-2.2 IU/L
Standard Deviation 10.46
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 63Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 2 (MAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they actually received. Only those participants with data available at specified time points were analyzed for the specific category titles.
Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. Standard Deviation (SD)=0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
2.2800 μmol/L
Standard Deviation 0.88304
|
2.8500 μmol/L
Standard Deviation 1.39621
|
2.1375 μmol/L
Standard Deviation 0.79158
|
1.7100 μmol/L
Standard Deviation 0.00000
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
-0.3420 μmol/L
Standard Deviation 0.96732
|
—
|
0.0214 μmol/L
Standard Deviation 0.51249
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
-0.0428 μmol/L
Standard Deviation 1.13750
|
0.3135 μmol/L
Standard Deviation 0.97585
|
—
|
0.4845 μmol/L
Standard Deviation 0.54524
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
-0.3420 μmol/L
Standard Deviation 1.20915
|
—
|
0.2565 μmol/L
Standard Deviation 0.78095
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
-0.2993 μmol/L
Standard Deviation 1.01044
|
0.0570 μmol/L
Standard Deviation 0.82837
|
—
|
0.8550 μmol/L
Standard Deviation 0.47141
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 8
|
-0.1710 μmol/L
Standard Deviation 0.48366
|
—
|
0.3420 μmol/L
Standard Deviation 0.69611
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 11
|
0.5130 μmol/L
Standard Deviation 0.72549
|
0.5130 μmol/L
Standard Deviation 0.60859
|
—
|
0.7695 μmol/L
Standard Deviation 0.58989
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 12
|
-0.5985 μmol/L
Standard Deviation 1.81373
|
—
|
0.4061 μmol/L
Standard Deviation 0.78062
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
-0.5558 μmol/L
Standard Deviation 0.68932
|
-0.2280 μmol/L
Standard Deviation 0.95923
|
—
|
0.2850 μmol/L
Standard Deviation 0.33625
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 15
|
0.1710 μmol/L
Standard Deviation 0.96732
|
—
|
0.7481 μmol/L
Standard Deviation 0.46551
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
-0.4275 μmol/L
Standard Deviation 0.86632
|
-0.1140 μmol/L
Standard Deviation 1.00100
|
—
|
0.8835 μmol/L
Standard Deviation 0.34905
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
-0.8208 μmol/L
Standard Deviation 1.13041
|
-0.8265 μmol/L
Standard Deviation 0.87472
|
-0.0428 μmol/L
Standard Deviation 0.67632
|
0.1710 μmol/L
Standard Deviation 0.49561
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 35
|
-0.4845 μmol/L
Standard Deviation 0.79043
|
-0.9690 μmol/L
Standard Deviation 0.91556
|
0.0000 μmol/L
Standard Deviation 0.80725
|
0.0855 μmol/L
Standard Deviation 0.41536
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 42
|
-0.2280 μmol/L
Standard Deviation 0.54791
|
-0.7695 μmol/L
Standard Deviation 0.80024
|
-0.1069 μmol/L
Standard Deviation 1.08896
|
-0.1140 μmol/L
Standard Deviation 0.35322
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 49
|
-0.2736 μmol/L
Standard Deviation 0.35459
|
-0.6270 μmol/L
Standard Deviation 0.84928
|
0.0641 μmol/L
Standard Deviation 0.45645
|
0.1995 μmol/L
Standard Deviation 0.59646
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 56
|
-0.3705 μmol/L
Standard Deviation 0.83364
|
-0.7866 μmol/L
Standard Deviation 0.82542
|
-0.2565 μmol/L
Standard Deviation 0.62663
|
0.0855 μmol/L
Standard Deviation 0.49265
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
1.7955 μmol/L
Standard Deviation 0.36275
|
—
|
2.5864 μmol/L
Standard Deviation 2.03655
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
-0.0855 μmol/L
Standard Deviation 2.68748
|
3.7620 μmol/L
Standard Deviation 4.99952
|
—
|
4.8165 μmol/L
Standard Deviation 3.79823
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 8
|
2.0520 μmol/L
Standard Deviation 2.90197
|
—
|
4.8094 μmol/L
Standard Deviation 3.07316
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 11
|
-0.8550 μmol/L
Standard Deviation 3.62746
|
3.6765 μmol/L
Standard Deviation 2.12893
|
—
|
4.7880 μmol/L
Standard Deviation 1.89494
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 12
|
-3.0780 μmol/L
Standard Deviation 6.77125
|
—
|
6.0705 μmol/L
Standard Deviation 2.04180
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
-3.2918 μmol/L
Standard Deviation 0.94050
|
-0.8550 μmol/L
Standard Deviation 5.47307
|
—
|
5.7000 μmol/L
Standard Deviation 1.55099
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 15
|
1.0260 μmol/L
Standard Deviation 1.93464
|
—
|
5.3651 μmol/L
Standard Deviation 2.82455
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
-3.0780 μmol/L
Standard Deviation 1.45769
|
0.7125 μmol/L
Standard Deviation 4.72334
|
—
|
6.6975 μmol/L
Standard Deviation 1.87139
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 22
|
5.3865 μmol/L
Standard Deviation 0.12092
|
—
|
8.4645 μmol/L
Standard Deviation 4.99216
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
-4.0014 μmol/L
Standard Deviation 3.67869
|
-4.7880 μmol/L
Standard Deviation 6.47907
|
0.1069 μmol/L
Standard Deviation 3.43820
|
1.5105 μmol/L
Standard Deviation 3.13339
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 35
|
-2.6790 μmol/L
Standard Deviation 2.91336
|
-4.3320 μmol/L
Standard Deviation 5.66489
|
0.6840 μmol/L
Standard Deviation 1.99837
|
0.8550 μmol/L
Standard Deviation 1.00294
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 42
|
-1.3395 μmol/L
Standard Deviation 1.08913
|
-4.3605 μmol/L
Standard Deviation 5.70510
|
0.5985 μmol/L
Standard Deviation 4.89669
|
0.6270 μmol/L
Standard Deviation 2.71598
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 49
|
-0.7866 μmol/L
Standard Deviation 1.70400
|
-2.9640 μmol/L
Standard Deviation 4.81803
|
1.5604 μmol/L
Standard Deviation 2.81789
|
1.5105 μmol/L
Standard Deviation 2.40233
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 63
|
-3.0495 μmol/L
Standard Deviation 1.72504
|
-4.7595 μmol/L
Standard Deviation 5.86150
|
-0.6413 μmol/L
Standard Deviation 2.44536
|
1.9095 μmol/L
Standard Deviation 2.35811
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
0.0428 μmol/L
Standard Deviation 0.84208
|
0.2565 μmol/L
Standard Deviation 0.67323
|
—
|
0.4275 μmol/L
Standard Deviation 0.40103
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 22
|
0.9405 μmol/L
Standard Deviation 1.08824
|
—
|
1.0901 μmol/L
Standard Deviation 0.85225
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 63
|
-0.5130 μmol/L
Standard Deviation 0.64890
|
-0.9405 μmol/L
Standard Deviation 1.25542
|
-0.2779 μmol/L
Standard Deviation 0.80174
|
0.2565 μmol/L
Standard Deviation 0.51584
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
11.9700 μmol/L
Standard Deviation 3.42000
|
15.1050 μmol/L
Standard Deviation 6.87553
|
9.6188 μmol/L
Standard Deviation 3.53265
|
8.2650 μmol/L
Standard Deviation 1.28724
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
-0.0855 μmol/L
Standard Deviation 2.38789
|
2.8500 μmol/L
Standard Deviation 3.18017
|
—
|
3.3915 μmol/L
Standard Deviation 2.22541
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
0.5985 μmol/L
Standard Deviation 1.33007
|
—
|
3.6338 μmol/L
Standard Deviation 2.33168
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
-1.6673 μmol/L
Standard Deviation 1.34192
|
1.3965 μmol/L
Standard Deviation 4.31166
|
—
|
6.6120 μmol/L
Standard Deviation 2.54018
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 56
|
-1.8525 μmol/L
Standard Deviation 2.73047
|
-6.0534 μmol/L
Standard Deviation 4.17394
|
-1.3039 μmol/L
Standard Deviation 2.45421
|
0.5415 μmol/L
Standard Deviation 1.86199
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 63Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 2 (MAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they actually received. Only those participants with data available at specified time points were analyzed for the specific category titles.
Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Baseline (Day 1)
|
66.2 IU/L
Standard Deviation 16.75
|
53.7 IU/L
Standard Deviation 10.01
|
57.5 IU/L
Standard Deviation 21.37
|
56.7 IU/L
Standard Deviation 11.41
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 2
|
4.0 IU/L
Standard Deviation 8.45
|
-1.7 IU/L
Standard Deviation 3.33
|
—
|
-0.5 IU/L
Standard Deviation 2.81
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 7
|
-0.3 IU/L
Standard Deviation 5.56
|
-4.8 IU/L
Standard Deviation 7.47
|
—
|
-0.2 IU/L
Standard Deviation 5.27
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 8
|
0.0 IU/L
Standard Deviation 8.49
|
—
|
-1.8 IU/L
Standard Deviation 3.77
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 28
|
-2.0 IU/L
Standard Deviation 4.85
|
-4.5 IU/L
Standard Deviation 6.69
|
2.3 IU/L
Standard Deviation 5.70
|
2.8 IU/L
Standard Deviation 3.76
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 56
|
2.8 IU/L
Standard Deviation 9.20
|
-3.6 IU/L
Standard Deviation 3.21
|
5.3 IU/L
Standard Deviation 6.90
|
-0.2 IU/L
Standard Deviation 4.96
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 3
|
-2.0 IU/L
Standard Deviation 1.41
|
—
|
2.0 IU/L
Standard Deviation 2.33
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 5
|
1.5 IU/L
Standard Deviation 8.96
|
0.5 IU/L
Standard Deviation 3.83
|
—
|
-2.8 IU/L
Standard Deviation 2.64
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 6
|
-6.0 IU/L
Standard Deviation 4.24
|
—
|
2.0 IU/L
Standard Deviation 5.45
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 7
|
4.8 IU/L
Standard Deviation 8.38
|
5.7 IU/L
Standard Deviation 7.81
|
—
|
-3.0 IU/L
Standard Deviation 3.79
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 11
|
9.0 IU/L
Standard Deviation 5.66
|
4.0 IU/L
Standard Deviation 11.28
|
—
|
-4.7 IU/L
Standard Deviation 4.72
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 12
|
-2.0 IU/L
Standard Deviation 1.41
|
—
|
2.9 IU/L
Standard Deviation 9.48
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 35
|
6.3 IU/L
Standard Deviation 5.50
|
17.8 IU/L
Standard Deviation 26.69
|
7.5 IU/L
Standard Deviation 7.29
|
3.3 IU/L
Standard Deviation 12.23
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 42
|
8.0 IU/L
Standard Deviation 8.65
|
8.8 IU/L
Standard Deviation 7.19
|
4.0 IU/L
Standard Deviation 6.74
|
1.7 IU/L
Standard Deviation 8.07
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 49
|
0.2 IU/L
Standard Deviation 1.10
|
5.2 IU/L
Standard Deviation 7.60
|
2.3 IU/L
Standard Deviation 6.34
|
-2.5 IU/L
Standard Deviation 5.96
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 63
|
-3.5 IU/L
Standard Deviation 6.53
|
0.3 IU/L
Standard Deviation 3.88
|
2.1 IU/L
Standard Deviation 6.31
|
-4.3 IU/L
Standard Deviation 5.92
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Baseline (Day 1)
|
16.2 IU/L
Standard Deviation 2.99
|
19.2 IU/L
Standard Deviation 4.12
|
14.9 IU/L
Standard Deviation 3.14
|
17.8 IU/L
Standard Deviation 3.54
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 2
|
-1.3 IU/L
Standard Deviation 2.06
|
-2.0 IU/L
Standard Deviation 2.68
|
—
|
-0.3 IU/L
Standard Deviation 1.51
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 3
|
-1.0 IU/L
Standard Deviation 1.41
|
—
|
1.4 IU/L
Standard Deviation 3.02
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 5
|
2.8 IU/L
Standard Deviation 3.86
|
-0.7 IU/L
Standard Deviation 3.50
|
—
|
-2.2 IU/L
Standard Deviation 2.04
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 6
|
-1.5 IU/L
Standard Deviation 0.71
|
—
|
0.4 IU/L
Standard Deviation 3.89
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 7
|
3.8 IU/L
Standard Deviation 4.11
|
5.3 IU/L
Standard Deviation 9.73
|
—
|
-1.8 IU/L
Standard Deviation 3.06
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 8
|
-1.5 IU/L
Standard Deviation 0.71
|
—
|
0.6 IU/L
Standard Deviation 2.88
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 11
|
2.0 IU/L
Standard Deviation 1.41
|
2.0 IU/L
Standard Deviation 6.06
|
—
|
-4.0 IU/L
Standard Deviation 2.53
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 12
|
0.0 IU/L
Standard Deviation 0.00
|
—
|
1.4 IU/L
Standard Deviation 4.44
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 14
|
8.8 IU/L
Standard Deviation 14.36
|
3.7 IU/L
Standard Deviation 6.35
|
—
|
-2.2 IU/L
Standard Deviation 2.93
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 15
|
-0.5 IU/L
Standard Deviation 0.71
|
—
|
1.1 IU/L
Standard Deviation 4.79
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 21
|
1.0 IU/L
Standard Deviation 1.15
|
4.2 IU/L
Standard Deviation 5.81
|
—
|
1.0 IU/L
Standard Deviation 3.10
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 22
|
1.0 IU/L
Standard Deviation 0.00
|
—
|
3.0 IU/L
Standard Deviation 3.02
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 28
|
7.8 IU/L
Standard Deviation 9.31
|
2.3 IU/L
Standard Deviation 6.22
|
7.0 IU/L
Standard Deviation 17.57
|
31.7 IU/L
Standard Deviation 81.01
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 42
|
5.3 IU/L
Standard Deviation 7.71
|
3.2 IU/L
Standard Deviation 5.27
|
1.0 IU/L
Standard Deviation 2.27
|
0.2 IU/L
Standard Deviation 3.87
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 3
|
-0.5 IU/L
Standard Deviation 4.95
|
—
|
0.9 IU/L
Standard Deviation 3.31
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 5
|
-0.8 IU/L
Standard Deviation 4.50
|
-3.8 IU/L
Standard Deviation 5.98
|
—
|
0.5 IU/L
Standard Deviation 4.85
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 6
|
-4.5 IU/L
Standard Deviation 3.54
|
—
|
-1.9 IU/L
Standard Deviation 3.40
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 11
|
-7.5 IU/L
Standard Deviation 3.54
|
-2.0 IU/L
Standard Deviation 5.48
|
—
|
-2.3 IU/L
Standard Deviation 5.05
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 12
|
2.5 IU/L
Standard Deviation 4.95
|
—
|
0.8 IU/L
Standard Deviation 3.24
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 14
|
4.5 IU/L
Standard Deviation 14.57
|
-6.0 IU/L
Standard Deviation 6.16
|
—
|
1.3 IU/L
Standard Deviation 4.37
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 15
|
-2.5 IU/L
Standard Deviation 6.36
|
—
|
0.5 IU/L
Standard Deviation 4.99
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 21
|
-3.0 IU/L
Standard Deviation 3.16
|
-3.2 IU/L
Standard Deviation 9.02
|
—
|
0.8 IU/L
Standard Deviation 4.62
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 22
|
2.0 IU/L
Standard Deviation 5.66
|
—
|
5.1 IU/L
Standard Deviation 3.94
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 35
|
-2.0 IU/L
Standard Deviation 5.83
|
-0.7 IU/L
Standard Deviation 8.62
|
2.4 IU/L
Standard Deviation 7.41
|
-3.7 IU/L
Standard Deviation 3.61
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 42
|
1.5 IU/L
Standard Deviation 6.47
|
-2.3 IU/L
Standard Deviation 5.43
|
4.6 IU/L
Standard Deviation 9.64
|
1.0 IU/L
Standard Deviation 4.73
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 49
|
0.8 IU/L
Standard Deviation 7.89
|
-2.7 IU/L
Standard Deviation 7.03
|
1.3 IU/L
Standard Deviation 6.76
|
-2.7 IU/L
Standard Deviation 4.55
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 63
|
0.3 IU/L
Standard Deviation 5.05
|
0.2 IU/L
Standard Deviation 5.95
|
1.3 IU/L
Standard Deviation 4.37
|
0.7 IU/L
Standard Deviation 2.88
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Baseline (Day 1)
|
18.7 IU/L
Standard Deviation 11.98
|
19.0 IU/L
Standard Deviation 6.93
|
16.3 IU/L
Standard Deviation 5.04
|
19.5 IU/L
Standard Deviation 7.69
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 2
|
-1.5 IU/L
Standard Deviation 5.80
|
0.2 IU/L
Standard Deviation 2.64
|
—
|
0.3 IU/L
Standard Deviation 2.07
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 8
|
-6.0 IU/L
Standard Deviation 2.83
|
—
|
0.5 IU/L
Standard Deviation 6.02
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 14
|
15.8 IU/L
Standard Deviation 17.21
|
10.5 IU/L
Standard Deviation 13.85
|
—
|
-2.8 IU/L
Standard Deviation 5.53
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 15
|
-1.0 IU/L
Standard Deviation 2.83
|
—
|
5.3 IU/L
Standard Deviation 10.74
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 21
|
7.0 IU/L
Standard Deviation 4.69
|
13.8 IU/L
Standard Deviation 15.28
|
—
|
3.7 IU/L
Standard Deviation 9.48
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 22
|
0.5 IU/L
Standard Deviation 6.36
|
—
|
7.9 IU/L
Standard Deviation 10.29
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 28
|
12.0 IU/L
Standard Deviation 15.98
|
8.5 IU/L
Standard Deviation 9.65
|
10.4 IU/L
Standard Deviation 9.38
|
14.2 IU/L
Standard Deviation 37.02
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 56
|
0.3 IU/L
Standard Deviation 3.33
|
0.8 IU/L
Standard Deviation 8.44
|
1.8 IU/L
Standard Deviation 6.71
|
-4.8 IU/L
Standard Deviation 2.48
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 35
|
3.8 IU/L
Standard Deviation 4.67
|
5.5 IU/L
Standard Deviation 7.29
|
4.6 IU/L
Standard Deviation 5.68
|
1.0 IU/L
Standard Deviation 6.42
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 49
|
2.4 IU/L
Standard Deviation 2.41
|
0.3 IU/L
Standard Deviation 4.03
|
1.3 IU/L
Standard Deviation 3.20
|
-1.3 IU/L
Standard Deviation 4.13
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 56
|
1.8 IU/L
Standard Deviation 2.64
|
0.4 IU/L
Standard Deviation 3.85
|
2.0 IU/L
Standard Deviation 7.46
|
-1.3 IU/L
Standard Deviation 1.63
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 63
|
-1.0 IU/L
Standard Deviation 1.41
|
0.7 IU/L
Standard Deviation 4.03
|
1.3 IU/L
Standard Deviation 4.30
|
-0.8 IU/L
Standard Deviation 3.54
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 3 (Single Dose) who received 1 single dose of study treatment. The participants were analyzed according to the treatment they actually received.
Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
0.2565 μmol/L
Standard Deviation 0.40103
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 4
|
0.1710 μmol/L
Standard Deviation 0.55146
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
-0.0570 μmol/L
Standard Deviation 0.62752
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
-0.1425 μmol/L
Standard Deviation 0.39614
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 35
|
-0.1425 μmol/L
Standard Deviation 0.22729
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 42
|
-0.1026 μmol/L
Standard Deviation 0.72145
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 49
|
-0.3420 μmol/L
Standard Deviation 0.50727
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
9.9750 μmol/L
Standard Deviation 4.24640
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
2.2800 μmol/L
Standard Deviation 1.65673
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 42
|
-2.0520 μmol/L
Standard Deviation 4.26987
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 49
|
-1.5105 μmol/L
Standard Deviation 2.99795
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
1.9950 μmol/L
Standard Deviation 0.69810
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
0.3135 μmol/L
Standard Deviation 0.43820
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
0.2850 μmol/L
Standard Deviation 0.50341
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
-0.2280 μmol/L
Standard Deviation 0.65488
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
-0.2565 μmol/L
Standard Deviation 0.23571
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
-0.0570 μmol/L
Standard Deviation 0.54791
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
1.0830 μmol/L
Standard Deviation 2.10730
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 4
|
0.4275 μmol/L
Standard Deviation 2.53346
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
0.7980 μmol/L
Standard Deviation 2.64396
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
1.3965 μmol/L
Standard Deviation 2.58072
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
-1.1115 μmol/L
Standard Deviation 3.11530
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
-1.1970 μmol/L
Standard Deviation 2.45193
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
-0.8835 μmol/L
Standard Deviation 2.28249
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
-1.0830 μmol/L
Standard Deviation 2.22344
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 35
|
0.1140 μmol/L
Standard Deviation 3.42285
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 3 (Single Dose) who received 1 single dose of study treatment. The participants were analyzed according to the treatment they actually received.
Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Baseline (Day 1)
|
55.7 IU/L
Standard Deviation 11.78
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 28
|
4.0 IU/L
Standard Deviation 12.20
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 35
|
3.8 IU/L
Standard Deviation 8.16
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 42
|
-0.2 IU/L
Standard Deviation 5.93
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 49
|
0.2 IU/L
Standard Deviation 6.05
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Baseline (Day 1)
|
24.3 IU/L
Standard Deviation 17.07
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 7
|
-3.0 IU/L
Standard Deviation 7.32
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 14
|
20.3 IU/L
Standard Deviation 48.50
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 21
|
7.0 IU/L
Standard Deviation 17.85
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 28
|
17.5 IU/L
Standard Deviation 41.15
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 35
|
2.3 IU/L
Standard Deviation 6.53
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 42
|
10.2 IU/L
Standard Deviation 28.44
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 49
|
2.0 IU/L
Standard Deviation 15.07
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 4
|
-1.8 IU/L
Standard Deviation 3.13
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 5
|
-2.2 IU/L
Standard Deviation 2.79
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 6
|
0.0 IU/L
Standard Deviation 3.63
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 7
|
-0.3 IU/L
Standard Deviation 3.08
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 14
|
6.8 IU/L
Standard Deviation 15.46
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 21
|
2.5 IU/L
Standard Deviation 4.04
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 28
|
7.0 IU/L
Standard Deviation 12.59
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 35
|
3.7 IU/L
Standard Deviation 6.35
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 42
|
10.6 IU/L
Standard Deviation 22.61
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 49
|
2.0 IU/L
Standard Deviation 6.87
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 2
|
-7.8 IU/L
Standard Deviation 3.13
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 3
|
-5.5 IU/L
Standard Deviation 3.02
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 4
|
-4.8 IU/L
Standard Deviation 2.86
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 5
|
-6.8 IU/L
Standard Deviation 5.64
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 6
|
-6.0 IU/L
Standard Deviation 2.61
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 7
|
-5.3 IU/L
Standard Deviation 4.89
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 14
|
4.5 IU/L
Standard Deviation 9.81
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALP, Day 21
|
2.3 IU/L
Standard Deviation 9.87
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 2
|
-5.2 IU/L
Standard Deviation 4.49
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 3
|
-5.2 IU/L
Standard Deviation 6.40
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 4
|
-5.2 IU/L
Standard Deviation 8.57
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 5
|
-5.7 IU/L
Standard Deviation 8.87
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
ALT, Day 6
|
-4.0 IU/L
Standard Deviation 8.44
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Baseline (Day 1)
|
17.5 IU/L
Standard Deviation 4.28
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 2
|
-2.3 IU/L
Standard Deviation 2.58
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALP, ALT and AST
AST, Day 3
|
-2.3 IU/L
Standard Deviation 3.33
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received 1 full dose of study treatment. The participants were analyzed according to the treatment they actually received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=10 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 63Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 2 (MAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they actually received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 49Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 3 (Single Dose) who received 1 single dose of study treatment. The participants were analyzed according to the treatment they actually received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of the liver panel parameters: ALT, ALP, AST, total bilirubin and direct bilirubin. The number of participants with any grade increase (from grade 1 \[mild\] to grade 4 \[potentially life-threatening\]) have been presented.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 4
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 2
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 4
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 4
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 1
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 2
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 4
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 1
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 3
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 4
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 1
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 2
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 3
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 1
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALP, Increase to Grade 3
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 1
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 2
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
AST, Increase to Grade 3
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Total Bilirubin, Increase to Grade 3
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
Direct Bilirubin, Increase to Grade 2
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the VH4004280 PK Set which included all participants in the Part 1 (SAD) Safety Set who received 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for pharmacokinetic (PK) analysis to determine AUC(0-inf). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. Geometric Coefficient of Variation was expressed in percentages.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-infinity]) Following Single Dose Administration of VH4004280
|
1396.25 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 28.02
|
16829.76 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.59
|
51168.22 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 51.76
|
174441.72 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 33.21
|
215339.87 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 42.90
|
—
|
PRIMARY outcome
Timeframe: At Days 1 and 14 for Part 2 (MAD): VH4004280 100 mg PiB and Part 2 (MAD): VH4004280 350 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB groupPopulation: The analysis was performed on the VH4004280 PK Set which included all participants in the Part 2 (MAD) Safety Set who received at least 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine AUC(0-t). For AUC, a linear trapezoidal method was employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (AUC[0-t]) Following Repeat Dose Administration of VH4004280
Day 2
|
—
|
15157.94 h*ng/mL
Geometric Coefficient of Variation 26.00
|
—
|
—
|
—
|
—
|
|
Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (AUC[0-t]) Following Repeat Dose Administration of VH4004280
Day 14
|
449239.54 h*ng/mL
Geometric Coefficient of Variation 53.50
|
—
|
1882862.73 h*ng/mL
Geometric Coefficient of Variation 37.66
|
—
|
—
|
—
|
|
Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (AUC[0-t]) Following Repeat Dose Administration of VH4004280
Day 15
|
—
|
1527149.1 h*ng/mL
Geometric Coefficient of Variation 26.00
|
—
|
—
|
—
|
—
|
|
Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (AUC[0-t]) Following Repeat Dose Administration of VH4004280
Day 1
|
6268.14 h*ng/mL
Geometric Coefficient of Variation 17.35
|
—
|
14869.75 h*ng/mL
Geometric Coefficient of Variation 23.49
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the VH4004280 PK Set which included all participants in the Part 1 (SAD) Safety Set who received 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4004280
|
13.49 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23.59
|
149.77 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27.34
|
438.80 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.60
|
1342.72 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.74
|
1630.95 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27.05
|
—
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the VH4004280 PK Set which included all participants in the Part 1 (SAD) Safety Set who received at least 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4004280
|
9.63 hours
Geometric Coefficient of Variation 9.13
|
9.90 hours
Geometric Coefficient of Variation 16.62
|
11.15 hours
Geometric Coefficient of Variation 40.09
|
10.31 hours
Geometric Coefficient of Variation 7.45
|
8.53 hours
Geometric Coefficient of Variation 20.71
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 49Population: The analysis was performed on the VH4004280 PK Set which included all participants in the Part 1 (SAD) Safety Set who received at least 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=7 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4004280
|
145.82 hours
Geometric Coefficient of Variation 40.60
|
149.91 hours
Geometric Coefficient of Variation 40.40
|
149.94 hours
Geometric Coefficient of Variation 43.47
|
177.58 hours
Geometric Coefficient of Variation 18.23
|
172.66 hours
Geometric Coefficient of Variation 29.45
|
—
|
PRIMARY outcome
Timeframe: At Days 1 and 14 for Part 2 (MAD): VH4004280 100 mg PiB and Part 2 (MAD): VH4004280 350 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB groupPopulation: The analysis was performed on the VH4004280 PK Set which included all participants in the Part 2 (MAD) Safety Set who received at least 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Cmax.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Cmax Following Repeat Dose Administration of VH4004280
Day 1
|
422.68 ng/mL
Geometric Coefficient of Variation 15.53
|
—
|
957.92 ng/mL
Geometric Coefficient of Variation 21.70
|
—
|
—
|
—
|
|
Part 2: Cmax Following Repeat Dose Administration of VH4004280
Day 2
|
—
|
972.51 ng/mL
Geometric Coefficient of Variation 26.49
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax Following Repeat Dose Administration of VH4004280
Day 14
|
1725.63 ng/mL
Geometric Coefficient of Variation 36.64
|
—
|
7573.63 ng/mL
Geometric Coefficient of Variation 66.10
|
—
|
—
|
—
|
|
Part 2: Cmax Following Repeat Dose Administration of VH4004280
Day 15
|
—
|
4487.14 ng/mL
Geometric Coefficient of Variation 42.27
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14 to Day 63 for Part 2 (MAD): VH4004280 100 mg PiB and Part 2 (MAD): VH4004280 350 mg PiB groups, and Day 15 to Day 63 for Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB groupPopulation: The analysis was performed on the VH4004280 PK Set which included all participants in the Part 2 (MAD) Safety Set who received at least 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine T1/2.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: T1/2 Following Repeat Dose Administration of VH4004280
Day 14 to Day 63
|
166.29 hours
Geometric Coefficient of Variation 34.95
|
—
|
147.93 hours
Geometric Coefficient of Variation 56.42
|
—
|
—
|
—
|
|
Part 2: T1/2 Following Repeat Dose Administration of VH4004280
Day 15 to Day 63
|
—
|
207.76 hours
Geometric Coefficient of Variation 35.36
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Days 1 and 14 for Part 2 (MAD): VH4004280 100 mg PiB and Part 2 (MAD): VH4004280 350 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB groupPopulation: The analysis was performed on the VH4004280 PK Set which included all participants in the Part 2 (MAD) Safety Set who received at least 1 full dose of study treatment with at least one non-missing PK assessment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for PK analysis to determine Tmax.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=6 Participants
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=8 Participants
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=6 Participants
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|
|
Part 2: Tmax Following Repeat Dose Administration of VH4004280
Day 1
|
9.28 hours
Geometric Coefficient of Variation 11.56
|
—
|
9.57 hours
Geometric Coefficient of Variation 15.66
|
—
|
—
|
—
|
|
Part 2: Tmax Following Repeat Dose Administration of VH4004280
Day 2
|
—
|
9.68 hours
Geometric Coefficient of Variation 13.38
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax Following Repeat Dose Administration of VH4004280
Day 14
|
9.58 hours
Geometric Coefficient of Variation 15.72
|
—
|
15.49 hours
Geometric Coefficient of Variation 50.84
|
—
|
—
|
—
|
|
Part 2: Tmax Following Repeat Dose Administration of VH4004280
Day 15
|
—
|
9.33 hours
Geometric Coefficient of Variation 21.14
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 (SAD): VH4004280 10 mg PiB
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 (SAD): VH4004280 50 mg PiB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 (SAD): VH4004280 150 mg PiB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 (SAD): VH4004280 450 mg PiB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 (SAD): VH4004280 900 mg PiB
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 (MAD): VH4004280 100 mg PiB
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2 (MAD): VH4004280 350 mg PiB
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 3 (Single Dose): VH4004280 450 mg Tablet
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-bottle (PiB)
n=10 participants at risk
Healthy participants were given a single oral dose of placebo on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 10 mg PiB
n=6 participants at risk
Healthy participants were given a single oral dose of 10 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 50 mg PiB
n=7 participants at risk
Healthy participants were given a single oral dose of 50 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 150 mg PiB
n=6 participants at risk
Healthy participants were given a single oral dose of 150 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 450 mg PiB
n=6 participants at risk
Healthy participants were given a single oral dose of 450 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 1 (SAD): VH4004280 900 mg PiB
n=6 participants at risk
Healthy participants were given a single oral dose of 900 mg VH4004280 PiB on Day 1 and were followed up to approximately Day 49.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
n=6 participants at risk
Healthy participants were given a dose of placebo once daily (QD) for a 14-day period and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 100 mg PiB
n=6 participants at risk
Healthy participants were given a dose of 100 mg VH4004280 PiB QD for a 14-day period and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 250 mg + Midazolam (MDZ) PiB
n=8 participants at risk
Healthy participants were given a dose of 250 mg VH4004280 PiB QD for a 14-day period, and a single dose of Midazolam on days 1, 2, and 15, and were followed up to approximately Day 63.
|
Part 2 (MAD): VH4004280 350 mg PiB
n=6 participants at risk
Healthy participants were given a dose of 350 mg VH4004280 PiB QD for a 14-day period and were followed up to approximately Day 63.
|
Part 3 (Single Dose): VH4004280 450 mg Tablet
n=6 participants at risk
Healthy participants were given a single oral dose of VH4004280 450 mg tablet at Day 1 and were followed up to approximately Day 49.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Bile acids increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
28.6%
2/7 • Number of events 2 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
28.6%
2/7 • Number of events 2 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
62.5%
5/8 • Number of events 5 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
10.0%
1/10 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
25.0%
2/8 • Number of events 2 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Body temperature increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
14.3%
1/7 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
25.0%
2/8 • Number of events 2 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
33.3%
2/6 • Number of events 2 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
14.3%
1/7 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
14.3%
1/7 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
14.3%
1/7 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/8 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/7 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
0.00%
0/6 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All cause mortality, serious adverse events (SAEs) and non-SAEs were collected up to a 49-day period following VH4004280 or placebo (i.e.: Day 49 for Parts 1 and 3, and Day 63 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER