Trial Outcomes & Findings for First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants (NCT NCT05393271)
NCT ID: NCT05393271
Last Updated: 2025-04-01
Results Overview
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
From Baseline (Day 1) and up to Day 28
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
Healthy participants were given a dose of placebo once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 200 mg PiB
Healthy participants were given a dose of VH4011499 200 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB
Healthy participants were given a dose of VH4011499 300 mg once daily and a single dose of Midazolam on Days 1, 2, and 15, and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 400 mg PiB
Healthy participants were given a dose of VH4011499 400 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 3 (Single Dose): VH4011499 200 mg Tablet
Healthy participants were given a dose of VH4011499 200 mg tablet on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
6
|
6
|
7
|
6
|
8
|
6
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
8
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
Healthy participants were given a dose of placebo once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 200 mg PiB
Healthy participants were given a dose of VH4011499 200 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB
Healthy participants were given a dose of VH4011499 300 mg once daily and a single dose of Midazolam on Days 1, 2, and 15, and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 400 mg PiB
Healthy participants were given a dose of VH4011499 400 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 3 (Single Dose): VH4011499 200 mg Tablet
Healthy participants were given a dose of VH4011499 200 mg tablet on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=10 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 Participants
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
n=7 Participants
Healthy participants were given a dose of placebo once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a dose of VH4011499 200 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB
n=8 Participants
Healthy participants were given a dose of VH4011499 300 mg once daily and a single dose of Midazolam on Days 1, 2, and 15, and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 400 mg PiB
n=6 Participants
Healthy participants were given a dose of VH4011499 400 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 3 (Single Dose): VH4011499 200 mg Tablet
n=6 Participants
Healthy participants were given a dose of VH4011499 200 mg tablet on Day 1 and were followed up until Day 28.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.8 Years
STANDARD_DEVIATION 11.17 • n=99 Participants
|
35.3 Years
STANDARD_DEVIATION 6.12 • n=107 Participants
|
36.5 Years
STANDARD_DEVIATION 7.48 • n=206 Participants
|
45.8 Years
STANDARD_DEVIATION 8.08 • n=157 Participants
|
40.0 Years
STANDARD_DEVIATION 12.05 • n=390 Participants
|
39.8 Years
STANDARD_DEVIATION 7.78 • n=16 Participants
|
37.6 Years
STANDARD_DEVIATION 11.18 • n=3 Participants
|
35.5 Years
STANDARD_DEVIATION 13.10 • n=6 Participants
|
38.9 Years
STANDARD_DEVIATION 11.81 • n=114 Participants
|
32.3 Years
STANDARD_DEVIATION 3.83 • n=23 Participants
|
37.2 Years
STANDARD_DEVIATION 9.91 • n=3 Participants
|
37.9 Years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
5 Participants
n=390 Participants
|
6 Participants
n=16 Participants
|
7 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
6 Participants
n=23 Participants
|
6 Participants
n=3 Participants
|
68 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
4 Participants
n=23 Participants
|
1 Participants
n=3 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=3 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they 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.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=10 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 Participants
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Adverse Events (AEs)
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 42Population: 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 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.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=7 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=8 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With AEs
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: 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 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.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With AEs
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they 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-a-bottle (PiB)
n=10 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 Participants
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With AEs by Severity
Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With AEs by Severity
Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With AEs by Severity
Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With AEs by Severity
Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With AEs by Severity
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 42Population: 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 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-a-bottle (PiB)
n=7 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=8 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With AEs by Severity
Grade 1
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Part 2: Number of Participants With AEs by Severity
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With AEs by Severity
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With AEs by Severity
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With AEs by Severity
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: 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 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With AEs by Severity
Grade 1
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With AEs by Severity
Grade 2
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With AEs by Severity
Grade 3
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With AEs by Severity
Grade 4
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Number of Participants With AEs by Severity
Grade 5
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 42Population: 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 received.
Number of participants who discontinued treatment due to AEs are presented.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=7 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=8 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants Discontinuing Treatment Due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they 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-a-bottle (PiB)
n=10 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 Participants
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
2.0520 Micromoles per Liter (μmol/L)
Standard Deviation 0.72100
|
2.8500 Micromoles per Liter (μmol/L)
Standard Deviation 1.39621
|
2.2800 Micromoles per Liter (μmol/L)
Standard Deviation 0.88304
|
1.9950 Micromoles per Liter (μmol/L)
Standard Deviation 0.69810
|
2.5650 Micromoles per Liter (μmol/L)
Standard Deviation 0.93661
|
3.1350 Micromoles per Liter (μmol/L)
Standard Deviation 1.28724
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
1.9665 Micromoles per Liter (μmol/L)
Standard Deviation 0.99465
|
2.5650 Micromoles per Liter (μmol/L)
Standard Deviation 0.64890
|
1.8525 Micromoles per Liter (μmol/L)
Standard Deviation 0.45134
|
1.7385 Micromoles per Liter (μmol/L)
Standard Deviation 0.56628
|
2.3940 Micromoles per Liter (μmol/L)
Standard Deviation 0.66668
|
3.1350 Micromoles per Liter (μmol/L)
Standard Deviation 1.34501
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 4
|
1.6416 Micromoles per Liter (μmol/L)
Standard Deviation 0.86895
|
2.7075 Micromoles per Liter (μmol/L)
Standard Deviation 0.78300
|
1.9095 Micromoles per Liter (μmol/L)
Standard Deviation 0.48867
|
1.6245 Micromoles per Liter (μmol/L)
Standard Deviation 0.81472
|
2.1375 Micromoles per Liter (μmol/L)
Standard Deviation 0.65562
|
2.7075 Micromoles per Liter (μmol/L)
Standard Deviation 1.01693
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
2.0007 Micromoles per Liter (μmol/L)
Standard Deviation 0.75641
|
2.7930 Micromoles per Liter (μmol/L)
Standard Deviation 0.84237
|
2.3085 Micromoles per Liter (μmol/L)
Standard Deviation 0.51584
|
1.7670 Micromoles per Liter (μmol/L)
Standard Deviation 0.35322
|
2.3940 Micromoles per Liter (μmol/L)
Standard Deviation 0.70919
|
3.2205 Micromoles per Liter (μmol/L)
Standard Deviation 1.33519
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
1.7955 Micromoles per Liter (μmol/L)
Standard Deviation 0.95123
|
2.3256 Micromoles per Liter (μmol/L)
Standard Deviation 0.75123
|
2.1660 Micromoles per Liter (μmol/L)
Standard Deviation 0.50341
|
1.4820 Micromoles per Liter (μmol/L)
Standard Deviation 0.27924
|
1.7385 Micromoles per Liter (μmol/L)
Standard Deviation 0.27396
|
2.2230 Micromoles per Liter (μmol/L)
Standard Deviation 1.08150
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
1.7613 Micromoles per Liter (μmol/L)
Standard Deviation 0.75641
|
2.1945 Micromoles per Liter (μmol/L)
Standard Deviation 0.46412
|
1.8810 Micromoles per Liter (μmol/L)
Standard Deviation 0.43260
|
1.7670 Micromoles per Liter (μmol/L)
Standard Deviation 0.45457
|
1.8525 Micromoles per Liter (μmol/L)
Standard Deviation 0.77549
|
2.6220 Micromoles per Liter (μmol/L)
Standard Deviation 1.56226
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
9.4050 Micromoles per Liter (μmol/L)
Standard Deviation 3.14793
|
12.8250 Micromoles per Liter (μmol/L)
Standard Deviation 5.59356
|
10.5450 Micromoles per Liter (μmol/L)
Standard Deviation 4.76555
|
11.6850 Micromoles per Liter (μmol/L)
Standard Deviation 2.27286
|
11.9700 Micromoles per Liter (μmol/L)
Standard Deviation 2.64912
|
13.6800 Micromoles per Liter (μmol/L)
Standard Deviation 6.11788
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
10.7901 Micromoles per Liter (μmol/L)
Standard Deviation 3.16075
|
11.9415 Micromoles per Liter (μmol/L)
Standard Deviation 2.89069
|
14.0790 Micromoles per Liter (μmol/L)
Standard Deviation 5.31220
|
10.8015 Micromoles per Liter (μmol/L)
Standard Deviation 2.30290
|
13.5945 Micromoles per Liter (μmol/L)
Standard Deviation 3.91997
|
18.5250 Micromoles per Liter (μmol/L)
Standard Deviation 9.28747
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 4
|
9.6444 Micromoles per Liter (μmol/L)
Standard Deviation 3.82385
|
11.2290 Micromoles per Liter (μmol/L)
Standard Deviation 2.62398
|
12.6825 Micromoles per Liter (μmol/L)
Standard Deviation 6.84634
|
10.1460 Micromoles per Liter (μmol/L)
Standard Deviation 4.36860
|
10.9155 Micromoles per Liter (μmol/L)
Standard Deviation 3.62974
|
15.6465 Micromoles per Liter (μmol/L)
Standard Deviation 7.08175
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
11.0637 Micromoles per Liter (μmol/L)
Standard Deviation 3.50450
|
12.4260 Micromoles per Liter (μmol/L)
Standard Deviation 2.91938
|
14.6490 Micromoles per Liter (μmol/L)
Standard Deviation 4.95448
|
9.9180 Micromoles per Liter (μmol/L)
Standard Deviation 2.30692
|
12.4545 Micromoles per Liter (μmol/L)
Standard Deviation 3.75331
|
17.7270 Micromoles per Liter (μmol/L)
Standard Deviation 7.77602
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
10.1574 Micromoles per Liter (μmol/L)
Standard Deviation 3.09505
|
12.3690 Micromoles per Liter (μmol/L)
Standard Deviation 2.20495
|
14.5350 Micromoles per Liter (μmol/L)
Standard Deviation 4.44205
|
10.9725 Micromoles per Liter (μmol/L)
Standard Deviation 2.79189
|
12.1980 Micromoles per Liter (μmol/L)
Standard Deviation 4.57011
|
16.0455 Micromoles per Liter (μmol/L)
Standard Deviation 6.69431
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
11.3373 Micromoles per Liter (μmol/L)
Standard Deviation 3.34901
|
13.1670 Micromoles per Liter (μmol/L)
Standard Deviation 3.67391
|
16.1766 Micromoles per Liter (μmol/L)
Standard Deviation 4.75214
|
9.5475 Micromoles per Liter (μmol/L)
Standard Deviation 4.17523
|
12.4545 Micromoles per Liter (μmol/L)
Standard Deviation 4.05153
|
18.1260 Micromoles per Liter (μmol/L)
Standard Deviation 6.43469
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
9.1390 Micromoles per Liter (μmol/L)
Standard Deviation 4.16071
|
9.4050 Micromoles per Liter (μmol/L)
Standard Deviation 4.37138
|
9.9750 Micromoles per Liter (μmol/L)
Standard Deviation 3.82011
|
7.5582 Micromoles per Liter (μmol/L)
Standard Deviation 2.48215
|
8.2422 Micromoles per Liter (μmol/L)
Standard Deviation 1.28762
|
10.2885 Micromoles per Liter (μmol/L)
Standard Deviation 4.38563
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
9.3195 Micromoles per Liter (μmol/L)
Standard Deviation 4.07958
|
9.7128 Micromoles per Liter (μmol/L)
Standard Deviation 2.89793
|
11.0580 Micromoles per Liter (μmol/L)
Standard Deviation 2.83606
|
8.2365 Micromoles per Liter (μmol/L)
Standard Deviation 2.10661
|
8.0370 Micromoles per Liter (μmol/L)
Standard Deviation 1.67894
|
10.5735 Micromoles per Liter (μmol/L)
Standard Deviation 4.85401
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
9.5247 Micromoles per Liter (μmol/L)
Standard Deviation 3.74733
|
10.4595 Micromoles per Liter (μmol/L)
Standard Deviation 2.49312
|
9.0345 Micromoles per Liter (μmol/L)
Standard Deviation 1.56132
|
9.7185 Micromoles per Liter (μmol/L)
Standard Deviation 2.67858
|
9.1770 Micromoles per Liter (μmol/L)
Standard Deviation 2.78613
|
13.4805 Micromoles per Liter (μmol/L)
Standard Deviation 9.10929
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
1.9152 Micromoles per Liter (μmol/L)
Standard Deviation 0.88964
|
2.7075 Micromoles per Liter (μmol/L)
Standard Deviation 0.52335
|
1.9950 Micromoles per Liter (μmol/L)
Standard Deviation 0.59891
|
1.9665 Micromoles per Liter (μmol/L)
Standard Deviation 0.49265
|
2.4510 Micromoles per Liter (μmol/L)
Standard Deviation 0.57905
|
3.2205 Micromoles per Liter (μmol/L)
Standard Deviation 1.41183
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
1.8639 Micromoles per Liter (μmol/L)
Standard Deviation 0.76239
|
2.8785 Micromoles per Liter (μmol/L)
Standard Deviation 0.95770
|
2.5365 Micromoles per Liter (μmol/L)
Standard Deviation 0.69601
|
1.9380 Micromoles per Liter (μmol/L)
Standard Deviation 0.51490
|
2.2515 Micromoles per Liter (μmol/L)
Standard Deviation 0.63447
|
3.0210 Micromoles per Liter (μmol/L)
Standard Deviation 1.28724
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
2.1375 Micromoles per Liter (μmol/L)
Standard Deviation 0.84256
|
2.9640 Micromoles per Liter (μmol/L)
Standard Deviation 0.76982
|
2.8044 Micromoles per Liter (μmol/L)
Standard Deviation 0.39367
|
1.6815 Micromoles per Liter (μmol/L)
Standard Deviation 0.67899
|
2.5650 Micromoles per Liter (μmol/L)
Standard Deviation 0.74144
|
3.3630 Micromoles per Liter (μmol/L)
Standard Deviation 1.19292
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
1.8620 Micromoles per Liter (μmol/L)
Standard Deviation 0.99872
|
2.3256 Micromoles per Liter (μmol/L)
Standard Deviation 1.03027
|
1.9095 Micromoles per Liter (μmol/L)
Standard Deviation 0.64362
|
1.4022 Micromoles per Liter (μmol/L)
Standard Deviation 0.44262
|
1.9494 Micromoles per Liter (μmol/L)
Standard Deviation 0.25933
|
2.0805 Micromoles per Liter (μmol/L)
Standard Deviation 0.93296
|
|
Part 1: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
10.4310 Micromoles per Liter (μmol/L)
Standard Deviation 2.89748
|
11.9985 Micromoles per Liter (μmol/L)
Standard Deviation 3.02320
|
15.1620 Micromoles per Liter (μmol/L)
Standard Deviation 7.84192
|
11.3145 Micromoles per Liter (μmol/L)
Standard Deviation 2.78980
|
12.5115 Micromoles per Liter (μmol/L)
Standard Deviation 3.76109
|
17.1000 Micromoles per Liter (μmol/L)
Standard Deviation 7.15263
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=10 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 Participants
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 3
|
53.1 International Units per Liter (IU/L)
Standard Deviation 16.11
|
54.8 International Units per Liter (IU/L)
Standard Deviation 19.36
|
50.7 International Units per Liter (IU/L)
Standard Deviation 6.86
|
58.2 International Units per Liter (IU/L)
Standard Deviation 6.91
|
66.3 International Units per Liter (IU/L)
Standard Deviation 21.08
|
51.7 International Units per Liter (IU/L)
Standard Deviation 8.12
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Baseline (Day 1)
|
56.4 International Units per Liter (IU/L)
Standard Deviation 20.82
|
57.2 International Units per Liter (IU/L)
Standard Deviation 18.96
|
53.7 International Units per Liter (IU/L)
Standard Deviation 6.50
|
63.0 International Units per Liter (IU/L)
Standard Deviation 5.14
|
72.0 International Units per Liter (IU/L)
Standard Deviation 29.39
|
55.0 International Units per Liter (IU/L)
Standard Deviation 8.07
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 2
|
52.3 International Units per Liter (IU/L)
Standard Deviation 17.23
|
56.3 International Units per Liter (IU/L)
Standard Deviation 20.54
|
51.2 International Units per Liter (IU/L)
Standard Deviation 5.34
|
59.3 International Units per Liter (IU/L)
Standard Deviation 5.99
|
67.8 International Units per Liter (IU/L)
Standard Deviation 22.63
|
48.8 International Units per Liter (IU/L)
Standard Deviation 7.05
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 4
|
54.5 International Units per Liter (IU/L)
Standard Deviation 15.63
|
55.5 International Units per Liter (IU/L)
Standard Deviation 19.27
|
52.5 International Units per Liter (IU/L)
Standard Deviation 6.53
|
65.0 International Units per Liter (IU/L)
Standard Deviation 9.82
|
69.5 International Units per Liter (IU/L)
Standard Deviation 24.60
|
52.7 International Units per Liter (IU/L)
Standard Deviation 8.21
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 5
|
53.9 International Units per Liter (IU/L)
Standard Deviation 14.89
|
54.0 International Units per Liter (IU/L)
Standard Deviation 17.55
|
52.2 International Units per Liter (IU/L)
Standard Deviation 7.22
|
62.2 International Units per Liter (IU/L)
Standard Deviation 9.41
|
68.0 International Units per Liter (IU/L)
Standard Deviation 21.56
|
53.0 International Units per Liter (IU/L)
Standard Deviation 9.34
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 6
|
54.2 International Units per Liter (IU/L)
Standard Deviation 15.85
|
53.3 International Units per Liter (IU/L)
Standard Deviation 17.45
|
52.3 International Units per Liter (IU/L)
Standard Deviation 8.36
|
65.0 International Units per Liter (IU/L)
Standard Deviation 9.90
|
67.5 International Units per Liter (IU/L)
Standard Deviation 18.72
|
52.7 International Units per Liter (IU/L)
Standard Deviation 9.14
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 7
|
54.6 International Units per Liter (IU/L)
Standard Deviation 15.88
|
54.2 International Units per Liter (IU/L)
Standard Deviation 17.52
|
49.4 International Units per Liter (IU/L)
Standard Deviation 4.56
|
65.0 International Units per Liter (IU/L)
Standard Deviation 10.64
|
66.7 International Units per Liter (IU/L)
Standard Deviation 22.71
|
54.0 International Units per Liter (IU/L)
Standard Deviation 10.00
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 14
|
52.8 International Units per Liter (IU/L)
Standard Deviation 16.59
|
59.6 International Units per Liter (IU/L)
Standard Deviation 24.99
|
53.2 International Units per Liter (IU/L)
Standard Deviation 7.14
|
63.6 International Units per Liter (IU/L)
Standard Deviation 9.71
|
77.2 International Units per Liter (IU/L)
Standard Deviation 22.62
|
53.2 International Units per Liter (IU/L)
Standard Deviation 7.83
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 21
|
58.5 International Units per Liter (IU/L)
Standard Deviation 22.15
|
58.8 International Units per Liter (IU/L)
Standard Deviation 21.48
|
52.8 International Units per Liter (IU/L)
Standard Deviation 6.24
|
66.8 International Units per Liter (IU/L)
Standard Deviation 11.72
|
70.2 International Units per Liter (IU/L)
Standard Deviation 20.49
|
51.3 International Units per Liter (IU/L)
Standard Deviation 6.71
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 21
|
20.5 International Units per Liter (IU/L)
Standard Deviation 11.40
|
26.0 International Units per Liter (IU/L)
Standard Deviation 20.25
|
24.8 International Units per Liter (IU/L)
Standard Deviation 10.55
|
18.2 International Units per Liter (IU/L)
Standard Deviation 3.92
|
19.5 International Units per Liter (IU/L)
Standard Deviation 9.71
|
18.7 International Units per Liter (IU/L)
Standard Deviation 3.61
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Baseline (Day 1)
|
15.0 International Units per Liter (IU/L)
Standard Deviation 3.53
|
20.7 International Units per Liter (IU/L)
Standard Deviation 9.65
|
20.3 International Units per Liter (IU/L)
Standard Deviation 3.27
|
16.2 International Units per Liter (IU/L)
Standard Deviation 2.64
|
20.0 International Units per Liter (IU/L)
Standard Deviation 8.07
|
21.7 International Units per Liter (IU/L)
Standard Deviation 4.27
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 28
|
20.3 International Units per Liter (IU/L)
Standard Deviation 10.19
|
32.0 International Units per Liter (IU/L)
Standard Deviation 26.50
|
22.8 International Units per Liter (IU/L)
Standard Deviation 5.85
|
15.7 International Units per Liter (IU/L)
Standard Deviation 2.42
|
15.8 International Units per Liter (IU/L)
Standard Deviation 2.71
|
19.8 International Units per Liter (IU/L)
Standard Deviation 4.49
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 28
|
56.1 International Units per Liter (IU/L)
Standard Deviation 17.62
|
59.0 International Units per Liter (IU/L)
Standard Deviation 19.38
|
55.7 International Units per Liter (IU/L)
Standard Deviation 7.61
|
68.5 International Units per Liter (IU/L)
Standard Deviation 12.14
|
68.7 International Units per Liter (IU/L)
Standard Deviation 20.75
|
51.5 International Units per Liter (IU/L)
Standard Deviation 7.77
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Baseline (Day 1)
|
13.9 International Units per Liter (IU/L)
Standard Deviation 4.38
|
28.5 International Units per Liter (IU/L)
Standard Deviation 16.01
|
24.7 International Units per Liter (IU/L)
Standard Deviation 9.03
|
16.0 International Units per Liter (IU/L)
Standard Deviation 4.34
|
23.8 International Units per Liter (IU/L)
Standard Deviation 13.11
|
21.7 International Units per Liter (IU/L)
Standard Deviation 3.44
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 2
|
14.2 International Units per Liter (IU/L)
Standard Deviation 4.96
|
34.0 International Units per Liter (IU/L)
Standard Deviation 24.66
|
23.2 International Units per Liter (IU/L)
Standard Deviation 8.98
|
16.0 International Units per Liter (IU/L)
Standard Deviation 4.98
|
19.5 International Units per Liter (IU/L)
Standard Deviation 10.56
|
21.8 International Units per Liter (IU/L)
Standard Deviation 8.93
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 3
|
15.7 International Units per Liter (IU/L)
Standard Deviation 5.56
|
33.7 International Units per Liter (IU/L)
Standard Deviation 25.95
|
22.3 International Units per Liter (IU/L)
Standard Deviation 8.04
|
16.5 International Units per Liter (IU/L)
Standard Deviation 5.92
|
17.5 International Units per Liter (IU/L)
Standard Deviation 8.80
|
20.5 International Units per Liter (IU/L)
Standard Deviation 8.48
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 4
|
16.0 International Units per Liter (IU/L)
Standard Deviation 6.36
|
30.0 International Units per Liter (IU/L)
Standard Deviation 19.93
|
23.2 International Units per Liter (IU/L)
Standard Deviation 7.31
|
15.8 International Units per Liter (IU/L)
Standard Deviation 5.78
|
18.0 International Units per Liter (IU/L)
Standard Deviation 8.72
|
20.3 International Units per Liter (IU/L)
Standard Deviation 7.28
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 5
|
16.1 International Units per Liter (IU/L)
Standard Deviation 5.36
|
27.2 International Units per Liter (IU/L)
Standard Deviation 16.82
|
22.2 International Units per Liter (IU/L)
Standard Deviation 6.79
|
16.2 International Units per Liter (IU/L)
Standard Deviation 6.11
|
18.2 International Units per Liter (IU/L)
Standard Deviation 9.33
|
19.2 International Units per Liter (IU/L)
Standard Deviation 4.96
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 6
|
17.4 International Units per Liter (IU/L)
Standard Deviation 6.45
|
24.7 International Units per Liter (IU/L)
Standard Deviation 14.35
|
22.0 International Units per Liter (IU/L)
Standard Deviation 5.44
|
17.2 International Units per Liter (IU/L)
Standard Deviation 6.49
|
17.8 International Units per Liter (IU/L)
Standard Deviation 8.33
|
19.2 International Units per Liter (IU/L)
Standard Deviation 4.49
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 7
|
18.7 International Units per Liter (IU/L)
Standard Deviation 7.56
|
23.5 International Units per Liter (IU/L)
Standard Deviation 12.63
|
23.6 International Units per Liter (IU/L)
Standard Deviation 5.46
|
17.3 International Units per Liter (IU/L)
Standard Deviation 6.53
|
18.2 International Units per Liter (IU/L)
Standard Deviation 9.15
|
20.0 International Units per Liter (IU/L)
Standard Deviation 5.59
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 14
|
19.7 International Units per Liter (IU/L)
Standard Deviation 6.40
|
21.2 International Units per Liter (IU/L)
Standard Deviation 9.50
|
21.5 International Units per Liter (IU/L)
Standard Deviation 6.09
|
16.4 International Units per Liter (IU/L)
Standard Deviation 3.44
|
21.6 International Units per Liter (IU/L)
Standard Deviation 9.24
|
19.7 International Units per Liter (IU/L)
Standard Deviation 3.72
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 28
|
24.9 International Units per Liter (IU/L)
Standard Deviation 17.39
|
28.2 International Units per Liter (IU/L)
Standard Deviation 24.81
|
23.8 International Units per Liter (IU/L)
Standard Deviation 6.62
|
16.8 International Units per Liter (IU/L)
Standard Deviation 5.42
|
18.5 International Units per Liter (IU/L)
Standard Deviation 7.48
|
18.2 International Units per Liter (IU/L)
Standard Deviation 3.54
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 2
|
14.2 International Units per Liter (IU/L)
Standard Deviation 3.43
|
23.0 International Units per Liter (IU/L)
Standard Deviation 13.55
|
19.2 International Units per Liter (IU/L)
Standard Deviation 3.66
|
14.3 International Units per Liter (IU/L)
Standard Deviation 3.01
|
15.0 International Units per Liter (IU/L)
Standard Deviation 3.29
|
18.3 International Units per Liter (IU/L)
Standard Deviation 5.57
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 3
|
15.3 International Units per Liter (IU/L)
Standard Deviation 3.16
|
21.0 International Units per Liter (IU/L)
Standard Deviation 9.86
|
18.2 International Units per Liter (IU/L)
Standard Deviation 3.49
|
14.0 International Units per Liter (IU/L)
Standard Deviation 2.37
|
14.7 International Units per Liter (IU/L)
Standard Deviation 2.16
|
17.8 International Units per Liter (IU/L)
Standard Deviation 4.45
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 4
|
15.1 International Units per Liter (IU/L)
Standard Deviation 3.31
|
17.5 International Units per Liter (IU/L)
Standard Deviation 6.83
|
19.3 International Units per Liter (IU/L)
Standard Deviation 3.61
|
14.0 International Units per Liter (IU/L)
Standard Deviation 2.28
|
14.8 International Units per Liter (IU/L)
Standard Deviation 2.64
|
17.8 International Units per Liter (IU/L)
Standard Deviation 3.54
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 5
|
15.2 International Units per Liter (IU/L)
Standard Deviation 2.53
|
15.5 International Units per Liter (IU/L)
Standard Deviation 4.51
|
18.5 International Units per Liter (IU/L)
Standard Deviation 3.02
|
14.2 International Units per Liter (IU/L)
Standard Deviation 2.04
|
14.8 International Units per Liter (IU/L)
Standard Deviation 2.40
|
17.0 International Units per Liter (IU/L)
Standard Deviation 2.76
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 6
|
15.1 International Units per Liter (IU/L)
Standard Deviation 3.41
|
14.8 International Units per Liter (IU/L)
Standard Deviation 3.97
|
18.3 International Units per Liter (IU/L)
Standard Deviation 3.56
|
14.3 International Units per Liter (IU/L)
Standard Deviation 2.07
|
15.0 International Units per Liter (IU/L)
Standard Deviation 1.79
|
17.2 International Units per Liter (IU/L)
Standard Deviation 3.31
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 7
|
16.0 International Units per Liter (IU/L)
Standard Deviation 3.62
|
17.0 International Units per Liter (IU/L)
Standard Deviation 5.14
|
19.0 International Units per Liter (IU/L)
Standard Deviation 2.55
|
14.7 International Units per Liter (IU/L)
Standard Deviation 2.42
|
14.8 International Units per Liter (IU/L)
Standard Deviation 2.48
|
19.2 International Units per Liter (IU/L)
Standard Deviation 5.19
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 14
|
18.0 International Units per Liter (IU/L)
Standard Deviation 5.61
|
17.4 International Units per Liter (IU/L)
Standard Deviation 6.66
|
20.7 International Units per Liter (IU/L)
Standard Deviation 5.65
|
17.4 International Units per Liter (IU/L)
Standard Deviation 2.30
|
17.6 International Units per Liter (IU/L)
Standard Deviation 3.21
|
19.5 International Units per Liter (IU/L)
Standard Deviation 4.76
|
|
Part 1: Absolute Values of Liver Panel Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 21
|
18.6 International Units per Liter (IU/L)
Standard Deviation 10.07
|
18.4 International Units per Liter (IU/L)
Standard Deviation 6.15
|
20.8 International Units per Liter (IU/L)
Standard Deviation 2.56
|
17.5 International Units per Liter (IU/L)
Standard Deviation 2.07
|
15.8 International Units per Liter (IU/L)
Standard Deviation 3.06
|
19.0 International Units per Liter (IU/L)
Standard Deviation 3.46
|
PRIMARY outcome
Timeframe: Up to Day 42Population: 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 received. Only those participants with data available at the specified timepoints were analyzed.
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-a-bottle (PiB)
n=7 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=8 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 22
|
1.7955 μmol/L
Standard Deviation 0.36275
|
—
|
2.0734 μmol/L
Standard Deviation 0.58838
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 35
|
1.4250 μmol/L
Standard Deviation 0.33625
|
1.4535 μmol/L
Standard Deviation 0.49265
|
1.3253 μmol/L
Standard Deviation 0.27037
|
2.8500 μmol/L
Standard Deviation 1.72927
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
12.1410 μmol/L
Standard Deviation 1.69281
|
—
|
12.5044 μmol/L
Standard Deviation 4.14193
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
1.6856 μmol/L
Standard Deviation 0.34805
|
1.7670 μmol/L
Standard Deviation 0.88304
|
1.6031 μmol/L
Standard Deviation 0.74782
|
2.5365 μmol/L
Standard Deviation 1.12089
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
1.8126 μmol/L
Standard Deviation 0.35459
|
1.9665 μmol/L
Standard Deviation 0.66448
|
—
|
2.8785 μmol/L
Standard Deviation 1.15177
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
1.8810 μmol/L
Standard Deviation 0.24183
|
—
|
2.1161 μmol/L
Standard Deviation 0.56298
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
1.9238 μmol/L
Standard Deviation 0.64551
|
2.3370 μmol/L
Standard Deviation 0.71466
|
—
|
2.4510 μmol/L
Standard Deviation 0.75447
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
1.8810 μmol/L
Standard Deviation 0.24183
|
—
|
2.4795 μmol/L
Standard Deviation 0.60630
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
2.1375 μmol/L
Standard Deviation 0.40706
|
2.0805 μmol/L
Standard Deviation 0.81949
|
—
|
3.2490 μmol/L
Standard Deviation 1.23310
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 8
|
1.6245 μmol/L
Standard Deviation 0.36275
|
—
|
2.2444 μmol/L
Standard Deviation 0.43296
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 11
|
2.1803 μmol/L
Standard Deviation 0.56499
|
2.1660 μmol/L
Standard Deviation 0.62752
|
—
|
3.1065 μmol/L
Standard Deviation 1.18678
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 12
|
1.3680 μmol/L
Standard Deviation 0.24183
|
—
|
2.2871 μmol/L
Standard Deviation 0.48312
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
2.1375 μmol/L
Standard Deviation 0.45242
|
2.1660 μmol/L
Standard Deviation 0.61813
|
—
|
3.0495 μmol/L
Standard Deviation 1.15683
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 15
|
1.9665 μmol/L
Standard Deviation 0.12092
|
—
|
2.2444 μmol/L
Standard Deviation 0.37058
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
1.9665 μmol/L
Standard Deviation 0.35596
|
1.9950 μmol/L
Standard Deviation 0.61813
|
—
|
2.8785 μmol/L
Standard Deviation 1.17190
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
1.5048 μmol/L
Standard Deviation 0.38994
|
1.3965 μmol/L
Standard Deviation 0.58657
|
1.2825 μmol/L
Standard Deviation 0.44778
|
1.8525 μmol/L
Standard Deviation 0.76026
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 42
|
1.5105 μmol/L
Standard Deviation 0.36542
|
1.1115 μmol/L
Standard Deviation 0.50438
|
1.7100 μmol/L
Standard Deviation 0.34200
|
2.5650 μmol/L
Standard Deviation 1.97947
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
10.5776 μmol/L
Standard Deviation 2.98545
|
10.0890 μmol/L
Standard Deviation 5.90780
|
9.5760 μmol/L
Standard Deviation 4.36923
|
12.8250 μmol/L
Standard Deviation 6.63163
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
12.1752 μmol/L
Standard Deviation 1.75806
|
13.6800 μmol/L
Standard Deviation 6.64924
|
—
|
16.8720 μmol/L
Standard Deviation 7.08416
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
12.0128 μmol/L
Standard Deviation 2.81458
|
13.7370 μmol/L
Standard Deviation 5.74282
|
—
|
15.7320 μmol/L
Standard Deviation 4.92171
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
10.0890 μmol/L
Standard Deviation 1.93464
|
—
|
12.7181 μmol/L
Standard Deviation 3.00651
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
12.8250 μmol/L
Standard Deviation 2.43837
|
13.2240 μmol/L
Standard Deviation 6.58176
|
—
|
16.4445 μmol/L
Standard Deviation 6.72047
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 8
|
9.9180 μmol/L
Standard Deviation 1.69281
|
—
|
13.1456 μmol/L
Standard Deviation 2.44141
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 11
|
12.7395 μmol/L
Standard Deviation 2.48392
|
13.8510 μmol/L
Standard Deviation 5.61547
|
—
|
16.4445 μmol/L
Standard Deviation 6.63464
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 12
|
10.6875 μmol/L
Standard Deviation 0.36275
|
—
|
13.8724 μmol/L
Standard Deviation 4.15402
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
11.7563 μmol/L
Standard Deviation 2.12378
|
13.4235 μmol/L
Standard Deviation 4.72994
|
—
|
15.6465 μmol/L
Standard Deviation 6.66132
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 15
|
11.7990 μmol/L
Standard Deviation 2.66014
|
—
|
13.9793 μmol/L
Standard Deviation 3.89270
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
12.5258 μmol/L
Standard Deviation 0.21517
|
11.9700 μmol/L
Standard Deviation 4.29070
|
—
|
16.9575 μmol/L
Standard Deviation 7.40445
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 22
|
11.2005 μmol/L
Standard Deviation 2.29739
|
—
|
12.2479 μmol/L
Standard Deviation 3.78959
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
8.5842 μmol/L
Standard Deviation 2.34276
|
8.1225 μmol/L
Standard Deviation 4.03031
|
6.6904 μmol/L
Standard Deviation 2.71983
|
8.3220 μmol/L
Standard Deviation 3.44499
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 35
|
9.1770 μmol/L
Standard Deviation 2.04534
|
8.2365 μmol/L
Standard Deviation 2.28761
|
7.5454 μmol/L
Standard Deviation 2.29136
|
15.0195 μmol/L
Standard Deviation 10.22140
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 42
|
9.7755 μmol/L
Standard Deviation 3.14643
|
7.4385 μmol/L
Standard Deviation 2.67712
|
8.6141 μmol/L
Standard Deviation 2.36934
|
13.0530 μmol/L
Standard Deviation 11.74742
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 42Population: 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 received. Only those participants with data available at the specified timepoints were analyzed.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=7 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=8 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 28
|
53.4 IU/L
Standard Deviation 11.67
|
60.0 IU/L
Standard Deviation 14.85
|
62.6 IU/L
Standard Deviation 19.26
|
51.3 IU/L
Standard Deviation 10.67
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 22
|
19.5 IU/L
Standard Deviation 10.61
|
—
|
17.0 IU/L
Standard Deviation 8.72
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 28
|
20.6 IU/L
Standard Deviation 9.29
|
16.7 IU/L
Standard Deviation 6.02
|
20.9 IU/L
Standard Deviation 7.59
|
22.3 IU/L
Standard Deviation 11.41
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 35
|
22.0 IU/L
Standard Deviation 11.76
|
28.0 IU/L
Standard Deviation 27.79
|
18.4 IU/L
Standard Deviation 5.93
|
18.3 IU/L
Standard Deviation 4.13
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Baseline (Day 1)
|
56.0 IU/L
Standard Deviation 16.78
|
59.5 IU/L
Standard Deviation 19.69
|
69.0 IU/L
Standard Deviation 22.43
|
53.8 IU/L
Standard Deviation 10.55
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 2
|
53.8 IU/L
Standard Deviation 12.15
|
58.3 IU/L
Standard Deviation 20.97
|
—
|
53.2 IU/L
Standard Deviation 10.91
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 3
|
47.0 IU/L
Standard Deviation 18.38
|
—
|
68.6 IU/L
Standard Deviation 22.56
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 5
|
52.5 IU/L
Standard Deviation 10.34
|
62.2 IU/L
Standard Deviation 23.59
|
—
|
54.3 IU/L
Standard Deviation 11.04
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 6
|
47.0 IU/L
Standard Deviation 18.38
|
—
|
69.3 IU/L
Standard Deviation 21.99
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 7
|
50.3 IU/L
Standard Deviation 12.04
|
59.3 IU/L
Standard Deviation 20.65
|
—
|
54.2 IU/L
Standard Deviation 10.46
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 8
|
47.0 IU/L
Standard Deviation 18.38
|
—
|
71.9 IU/L
Standard Deviation 24.31
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 11
|
50.3 IU/L
Standard Deviation 12.92
|
54.0 IU/L
Standard Deviation 18.07
|
—
|
51.2 IU/L
Standard Deviation 9.77
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 12
|
47.0 IU/L
Standard Deviation 18.38
|
—
|
64.0 IU/L
Standard Deviation 19.95
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 14
|
51.8 IU/L
Standard Deviation 12.76
|
61.0 IU/L
Standard Deviation 19.78
|
—
|
49.7 IU/L
Standard Deviation 9.20
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 15
|
50.5 IU/L
Standard Deviation 23.33
|
—
|
66.5 IU/L
Standard Deviation 22.60
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 21
|
49.5 IU/L
Standard Deviation 12.40
|
51.8 IU/L
Standard Deviation 14.30
|
—
|
50.8 IU/L
Standard Deviation 10.53
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 22
|
47.0 IU/L
Standard Deviation 18.38
|
—
|
63.8 IU/L
Standard Deviation 18.72
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 35
|
47.7 IU/L
Standard Deviation 12.71
|
63.0 IU/L
Standard Deviation 34.89
|
65.5 IU/L
Standard Deviation 17.88
|
49.0 IU/L
Standard Deviation 11.37
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 42
|
52.2 IU/L
Standard Deviation 12.64
|
60.3 IU/L
Standard Deviation 18.60
|
66.5 IU/L
Standard Deviation 22.53
|
53.5 IU/L
Standard Deviation 10.65
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Baseline (Day 1)
|
23.6 IU/L
Standard Deviation 8.30
|
15.8 IU/L
Standard Deviation 4.62
|
19.5 IU/L
Standard Deviation 5.71
|
19.8 IU/L
Standard Deviation 6.24
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 2
|
19.8 IU/L
Standard Deviation 6.30
|
16.0 IU/L
Standard Deviation 4.90
|
—
|
19.0 IU/L
Standard Deviation 6.03
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 3
|
23.5 IU/L
Standard Deviation 12.02
|
—
|
16.6 IU/L
Standard Deviation 4.47
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 5
|
17.0 IU/L
Standard Deviation 5.35
|
16.0 IU/L
Standard Deviation 4.65
|
—
|
17.3 IU/L
Standard Deviation 6.31
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 6
|
19.5 IU/L
Standard Deviation 9.19
|
—
|
15.6 IU/L
Standard Deviation 5.48
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 7
|
16.0 IU/L
Standard Deviation 4.24
|
14.5 IU/L
Standard Deviation 3.62
|
—
|
18.8 IU/L
Standard Deviation 7.47
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 8
|
20.5 IU/L
Standard Deviation 7.78
|
—
|
18.1 IU/L
Standard Deviation 7.86
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 11
|
15.3 IU/L
Standard Deviation 3.77
|
12.5 IU/L
Standard Deviation 3.73
|
—
|
19.5 IU/L
Standard Deviation 8.76
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 12
|
18.0 IU/L
Standard Deviation 8.49
|
—
|
14.8 IU/L
Standard Deviation 5.85
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 14
|
16.8 IU/L
Standard Deviation 4.19
|
12.2 IU/L
Standard Deviation 3.19
|
—
|
18.7 IU/L
Standard Deviation 7.31
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 15
|
26.0 IU/L
Standard Deviation 16.97
|
—
|
18.1 IU/L
Standard Deviation 7.75
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 21
|
16.0 IU/L
Standard Deviation 5.35
|
12.3 IU/L
Standard Deviation 3.33
|
—
|
18.3 IU/L
Standard Deviation 8.19
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 42
|
24.2 IU/L
Standard Deviation 10.38
|
14.8 IU/L
Standard Deviation 3.66
|
20.5 IU/L
Standard Deviation 5.93
|
21.8 IU/L
Standard Deviation 4.45
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Baseline (Day 1)
|
23.3 IU/L
Standard Deviation 7.45
|
17.3 IU/L
Standard Deviation 3.44
|
18.9 IU/L
Standard Deviation 2.70
|
17.7 IU/L
Standard Deviation 3.27
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 2
|
19.6 IU/L
Standard Deviation 2.61
|
16.5 IU/L
Standard Deviation 3.02
|
—
|
15.3 IU/L
Standard Deviation 3.08
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 3
|
19.0 IU/L
Standard Deviation 8.49
|
—
|
17.0 IU/L
Standard Deviation 2.98
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 5
|
18.0 IU/L
Standard Deviation 2.83
|
16.8 IU/L
Standard Deviation 2.04
|
—
|
14.0 IU/L
Standard Deviation 2.10
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 6
|
16.0 IU/L
Standard Deviation 7.07
|
—
|
16.0 IU/L
Standard Deviation 3.07
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 7
|
17.3 IU/L
Standard Deviation 1.71
|
16.3 IU/L
Standard Deviation 2.25
|
—
|
14.7 IU/L
Standard Deviation 1.63
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 8
|
17.0 IU/L
Standard Deviation 5.66
|
—
|
18.0 IU/L
Standard Deviation 4.69
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 11
|
15.5 IU/L
Standard Deviation 2.38
|
15.8 IU/L
Standard Deviation 3.54
|
—
|
13.3 IU/L
Standard Deviation 2.50
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 12
|
16.5 IU/L
Standard Deviation 4.95
|
—
|
15.9 IU/L
Standard Deviation 2.70
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 14
|
17.3 IU/L
Standard Deviation 3.10
|
16.7 IU/L
Standard Deviation 3.50
|
—
|
13.8 IU/L
Standard Deviation 2.14
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 15
|
20.0 IU/L
Standard Deviation 9.90
|
—
|
17.6 IU/L
Standard Deviation 4.17
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 21
|
16.5 IU/L
Standard Deviation 2.08
|
15.7 IU/L
Standard Deviation 2.73
|
—
|
15.0 IU/L
Standard Deviation 3.16
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 22
|
18.0 IU/L
Standard Deviation 4.24
|
—
|
16.6 IU/L
Standard Deviation 3.16
|
—
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 28
|
20.2 IU/L
Standard Deviation 4.27
|
17.5 IU/L
Standard Deviation 3.73
|
22.6 IU/L
Standard Deviation 8.19
|
20.7 IU/L
Standard Deviation 7.84
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 35
|
20.0 IU/L
Standard Deviation 6.63
|
26.3 IU/L
Standard Deviation 19.34
|
20.5 IU/L
Standard Deviation 3.55
|
20.2 IU/L
Standard Deviation 7.91
|
—
|
—
|
|
Part 2: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 42
|
21.7 IU/L
Standard Deviation 4.93
|
16.3 IU/L
Standard Deviation 1.75
|
19.8 IU/L
Standard Deviation 4.20
|
20.7 IU/L
Standard Deviation 3.27
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: 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 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
1.4250 IU/L
Standard Deviation 0.69810
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
2.1375 IU/L
Standard Deviation 0.97784
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
2.2515 IU/L
Standard Deviation 1.05642
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 4
|
1.9665 IU/L
Standard Deviation 0.94747
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
1.7784 IU/L
Standard Deviation 0.44591
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
2.3085 IU/L
Standard Deviation 1.11216
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
1.9950 IU/L
Standard Deviation 0.89619
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
1.9665 IU/L
Standard Deviation 0.69038
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
1.8525 IU/L
Standard Deviation 0.69601
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
2.6790 IU/L
Standard Deviation 2.39074
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
7.6950 IU/L
Standard Deviation 3.19912
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
14.2500 IU/L
Standard Deviation 7.57873
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
13.8225 IU/L
Standard Deviation 7.43283
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 4
|
12.2550 IU/L
Standard Deviation 6.56575
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
10.8756 IU/L
Standard Deviation 2.84755
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
14.5920 IU/L
Standard Deviation 8.80586
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
11.2290 IU/L
Standard Deviation 5.55123
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
11.7705 IU/L
Standard Deviation 6.12879
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
8.2365 IU/L
Standard Deviation 3.08827
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
14.4495 IU/L
Standard Deviation 15.05412
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: 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 received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 5
|
56.6 μmol/L
Standard Deviation 7.73
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 6
|
54.2 μmol/L
Standard Deviation 6.62
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 7
|
54.7 μmol/L
Standard Deviation 6.12
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Baseline (Day 1)
|
52.0 μmol/L
Standard Deviation 8.12
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 2
|
50.7 μmol/L
Standard Deviation 7.99
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 3
|
51.0 μmol/L
Standard Deviation 8.20
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 4
|
54.3 μmol/L
Standard Deviation 7.39
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 14
|
54.7 μmol/L
Standard Deviation 10.39
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 21
|
52.7 μmol/L
Standard Deviation 7.61
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALP, Day 28
|
56.3 μmol/L
Standard Deviation 8.52
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Baseline (Day 1)
|
12.7 μmol/L
Standard Deviation 4.03
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 2
|
15.2 μmol/L
Standard Deviation 6.74
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 3
|
15.0 μmol/L
Standard Deviation 6.60
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 4
|
15.0 μmol/L
Standard Deviation 8.32
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 5
|
13.0 μmol/L
Standard Deviation 4.42
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 6
|
15.2 μmol/L
Standard Deviation 6.85
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 7
|
15.0 μmol/L
Standard Deviation 5.87
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 14
|
17.5 μmol/L
Standard Deviation 8.96
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 21
|
19.2 μmol/L
Standard Deviation 10.26
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
ALT, Day 28
|
15.0 μmol/L
Standard Deviation 4.38
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Baseline
|
16.7 μmol/L
Standard Deviation 1.63
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 2
|
17.3 μmol/L
Standard Deviation 3.20
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 3
|
16.3 μmol/L
Standard Deviation 2.34
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 4
|
16.5 μmol/L
Standard Deviation 2.26
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 5
|
16.6 μmol/L
Standard Deviation 1.14
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 6
|
17.2 μmol/L
Standard Deviation 1.83
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 7
|
16.3 μmol/L
Standard Deviation 1.63
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 14
|
19.3 μmol/L
Standard Deviation 3.44
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 21
|
21.0 μmol/L
Standard Deviation 9.03
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Absolute Values of Liver Panel Parameters: ALT, ALP and AST
AST, Day 28
|
18.5 μmol/L
Standard Deviation 3.27
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 28Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. 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-a-bottle (PiB)
n=10 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 Participants
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
-0.1368 IU/L
Standard Deviation 0.54553
|
-0.1425 IU/L
Standard Deviation 1.54248
|
-0.2850 IU/L
Standard Deviation 0.84237
|
-0.0285 IU/L
Standard Deviation 0.45134
|
-0.1140 IU/L
Standard Deviation 0.62752
|
0.0855 IU/L
Standard Deviation 0.79289
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 4
|
0.2394 IU/L
Standard Deviation 2.41185
|
-1.5960 IU/L
Standard Deviation 5.05381
|
2.1375 IU/L
Standard Deviation 6.66747
|
-1.5390 IU/L
Standard Deviation 3.11577
|
-1.0545 IU/L
Standard Deviation 2.33568
|
1.9665 IU/L
Standard Deviation 5.79158
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
1.6587 IU/L
Standard Deviation 2.37773
|
-0.3990 IU/L
Standard Deviation 5.95676
|
4.1040 IU/L
Standard Deviation 5.26169
|
-1.7670 IU/L
Standard Deviation 2.50541
|
0.4845 IU/L
Standard Deviation 1.97774
|
4.0470 IU/L
Standard Deviation 7.46913
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
0.7524 IU/L
Standard Deviation 2.27886
|
-0.4560 IU/L
Standard Deviation 6.19451
|
3.9900 IU/L
Standard Deviation 6.70064
|
-0.7125 IU/L
Standard Deviation 1.83031
|
0.2280 IU/L
Standard Deviation 3.36078
|
2.3655 IU/L
Standard Deviation 8.26581
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
1.9323 IU/L
Standard Deviation 2.55682
|
0.3420 IU/L
Standard Deviation 6.36984
|
5.2326 IU/L
Standard Deviation 5.27972
|
-2.1375 IU/L
Standard Deviation 2.49859
|
0.4845 IU/L
Standard Deviation 2.42655
|
4.4460 IU/L
Standard Deviation 6.95867
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
-0.3610 IU/L
Standard Deviation 1.91460
|
-2.9070 IU/L
Standard Deviation 6.29108
|
-0.5700 IU/L
Standard Deviation 4.06486
|
-4.0698 IU/L
Standard Deviation 3.91698
|
-3.7278 IU/L
Standard Deviation 3.46966
|
-3.3915 IU/L
Standard Deviation 4.65725
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
-0.0855 IU/L
Standard Deviation 2.10399
|
-2.5992 IU/L
Standard Deviation 5.51776
|
0.5130 IU/L
Standard Deviation 3.87835
|
-3.4485 IU/L
Standard Deviation 2.88056
|
-3.9330 IU/L
Standard Deviation 2.82228
|
-3.1065 IU/L
Standard Deviation 3.89102
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
2.0520 IU/L
Standard Deviation 0.72100
|
2.8500 IU/L
Standard Deviation 1.39621
|
2.2800 IU/L
Standard Deviation 0.88304
|
1.9950 IU/L
Standard Deviation 0.69810
|
2.5650 IU/L
Standard Deviation 0.93661
|
3.1350 IU/L
Standard Deviation 1.28724
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
0.1197 IU/L
Standard Deviation 1.42169
|
-2.3655 IU/L
Standard Deviation 7.17501
|
-1.5105 IU/L
Standard Deviation 4.15838
|
-1.9665 IU/L
Standard Deviation 3.32770
|
-2.7930 IU/L
Standard Deviation 2.63510
|
-0.1995 IU/L
Standard Deviation 5.55096
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
-0.0855 IU/L
Standard Deviation 0.99465
|
-0.2850 IU/L
Standard Deviation 1.53963
|
-0.4275 IU/L
Standard Deviation 0.90968
|
-0.2565 IU/L
Standard Deviation 0.35459
|
-0.1710 IU/L
Standard Deviation 0.78734
|
0.0000 IU/L
Standard Deviation 1.14965
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 4
|
-0.4104 IU/L
Standard Deviation 0.49822
|
-0.1425 IU/L
Standard Deviation 1.53868
|
-0.3705 IU/L
Standard Deviation 0.90754
|
-0.3705 IU/L
Standard Deviation 0.62518
|
-0.4275 IU/L
Standard Deviation 0.55936
|
-0.4275 IU/L
Standard Deviation 0.84985
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
-0.0513 IU/L
Standard Deviation 0.58157
|
-0.0570 IU/L
Standard Deviation 1.84384
|
0.0285 IU/L
Standard Deviation 1.02267
|
-0.2280 IU/L
Standard Deviation 0.73085
|
-0.1710 IU/L
Standard Deviation 0.66668
|
0.0855 IU/L
Standard Deviation 1.00148
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
-0.1881 IU/L
Standard Deviation 0.49331
|
0.0285 IU/L
Standard Deviation 2.01872
|
0.2565 IU/L
Standard Deviation 1.30117
|
-0.0570 IU/L
Standard Deviation 0.56886
|
-0.3135 IU/L
Standard Deviation 0.63447
|
-0.1140 IU/L
Standard Deviation 1.30976
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
0.0855 IU/L
Standard Deviation 0.56571
|
0.1140 IU/L
Standard Deviation 1.77928
|
0.4104 IU/L
Standard Deviation 1.00148
|
-0.3135 IU/L
Standard Deviation 0.47656
|
0.0000 IU/L
Standard Deviation 0.61179
|
0.2280 IU/L
Standard Deviation 1.21719
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
-0.2280 IU/L
Standard Deviation 0.61655
|
-0.4104 IU/L
Standard Deviation 1.21277
|
-0.3705 IU/L
Standard Deviation 1.11040
|
-0.6498 IU/L
Standard Deviation 0.89999
|
-0.7866 IU/L
Standard Deviation 0.98678
|
-1.0545 IU/L
Standard Deviation 1.05087
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
-0.2565 IU/L
Standard Deviation 0.50502
|
-0.4104 IU/L
Standard Deviation 1.12523
|
-0.1140 IU/L
Standard Deviation 1.09047
|
-0.5130 IU/L
Standard Deviation 0.72549
|
-0.8265 IU/L
Standard Deviation 0.88138
|
-0.9120 IU/L
Standard Deviation 0.97735
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
-0.2907 IU/L
Standard Deviation 0.39532
|
-0.6555 IU/L
Standard Deviation 1.80457
|
-0.3990 IU/L
Standard Deviation 0.98331
|
-0.2280 IU/L
Standard Deviation 0.70643
|
-0.7125 IU/L
Standard Deviation 0.77549
|
-0.5130 IU/L
Standard Deviation 1.16982
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
9.4050 IU/L
Standard Deviation 3.14793
|
12.8250 IU/L
Standard Deviation 5.59356
|
10.5450 IU/L
Standard Deviation 4.76555
|
11.6850 IU/L
Standard Deviation 2.27286
|
11.9700 IU/L
Standard Deviation 2.64912
|
13.6800 IU/L
Standard Deviation 6.11788
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
1.3851 IU/L
Standard Deviation 2.24764
|
-0.8835 IU/L
Standard Deviation 4.85401
|
3.5340 IU/L
Standard Deviation 4.59817
|
-0.8835 IU/L
Standard Deviation 2.06171
|
1.6245 IU/L
Standard Deviation 2.72261
|
4.8450 IU/L
Standard Deviation 6.74934
|
|
Part 1: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
1.0260 IU/L
Standard Deviation 2.05042
|
-0.8265 IU/L
Standard Deviation 5.51609
|
4.6170 IU/L
Standard Deviation 7.54418
|
-0.3705 IU/L
Standard Deviation 1.79482
|
0.5415 IU/L
Standard Deviation 2.92088
|
3.4200 IU/L
Standard Deviation 7.47252
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 28Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. 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-a-bottle (PiB)
n=10 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 Participants
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 2
|
0.3 μmol/L
Standard Deviation 1.89
|
5.5 μmol/L
Standard Deviation 11.26
|
-1.5 μmol/L
Standard Deviation 3.39
|
0.0 μmol/L
Standard Deviation 1.55
|
-4.3 μmol/L
Standard Deviation 3.78
|
0.2 μmol/L
Standard Deviation 7.19
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 3
|
1.8 μmol/L
Standard Deviation 2.44
|
5.2 μmol/L
Standard Deviation 13.04
|
-2.3 μmol/L
Standard Deviation 3.08
|
0.5 μmol/L
Standard Deviation 2.43
|
-6.3 μmol/L
Standard Deviation 5.20
|
-1.2 μmol/L
Standard Deviation 7.14
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 5
|
2.2 μmol/L
Standard Deviation 3.49
|
-1.3 μmol/L
Standard Deviation 3.72
|
-2.5 μmol/L
Standard Deviation 3.73
|
0.2 μmol/L
Standard Deviation 2.48
|
-5.7 μmol/L
Standard Deviation 6.35
|
-2.5 μmol/L
Standard Deviation 5.21
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 4
|
0.1 μmol/L
Standard Deviation 2.33
|
-3.2 μmol/L
Standard Deviation 3.76
|
-1.0 μmol/L
Standard Deviation 2.10
|
-2.2 μmol/L
Standard Deviation 2.32
|
-5.2 μmol/L
Standard Deviation 6.62
|
-3.8 μmol/L
Standard Deviation 4.02
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 21
|
6.6 μmol/L
Standard Deviation 8.78
|
-2.2 μmol/L
Standard Deviation 13.50
|
0.2 μmol/L
Standard Deviation 8.40
|
2.2 μmol/L
Standard Deviation 3.60
|
-4.3 μmol/L
Standard Deviation 6.89
|
-3.0 μmol/L
Standard Deviation 4.47
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 6
|
0.1 μmol/L
Standard Deviation 2.18
|
-5.8 μmol/L
Standard Deviation 6.11
|
-2.0 μmol/L
Standard Deviation 2.10
|
-1.8 μmol/L
Standard Deviation 2.64
|
-5.0 μmol/L
Standard Deviation 7.24
|
-4.5 μmol/L
Standard Deviation 3.21
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 7
|
1.0 μmol/L
Standard Deviation 3.16
|
-3.7 μmol/L
Standard Deviation 7.84
|
-2.0 μmol/L
Standard Deviation 1.58
|
-1.5 μmol/L
Standard Deviation 2.17
|
-5.2 μmol/L
Standard Deviation 7.08
|
-2.5 μmol/L
Standard Deviation 3.78
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 14
|
2.7 μmol/L
Standard Deviation 5.79
|
-3.6 μmol/L
Standard Deviation 5.03
|
0.3 μmol/L
Standard Deviation 2.88
|
0.8 μmol/L
Standard Deviation 0.84
|
-3.0 μmol/L
Standard Deviation 6.28
|
-2.2 μmol/L
Standard Deviation 4.96
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 21
|
3.6 μmol/L
Standard Deviation 7.57
|
-2.6 μmol/L
Standard Deviation 6.11
|
0.5 μmol/L
Standard Deviation 4.51
|
1.3 μmol/L
Standard Deviation 2.34
|
-4.2 μmol/L
Standard Deviation 5.78
|
-2.7 μmol/L
Standard Deviation 2.73
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 28
|
5.3 μmol/L
Standard Deviation 8.63
|
11.3 μmol/L
Standard Deviation 17.81
|
2.5 μmol/L
Standard Deviation 4.28
|
-0.5 μmol/L
Standard Deviation 2.43
|
-4.2 μmol/L
Standard Deviation 7.44
|
-1.8 μmol/L
Standard Deviation 3.19
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 4
|
2.1 μmol/L
Standard Deviation 3.87
|
1.5 μmol/L
Standard Deviation 6.02
|
-1.5 μmol/L
Standard Deviation 4.28
|
-0.2 μmol/L
Standard Deviation 2.23
|
-5.8 μmol/L
Standard Deviation 5.64
|
-1.3 μmol/L
Standard Deviation 6.47
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 6
|
3.5 μmol/L
Standard Deviation 4.97
|
-3.8 μmol/L
Standard Deviation 3.87
|
-2.7 μmol/L
Standard Deviation 5.54
|
1.2 μmol/L
Standard Deviation 3.19
|
-6.0 μmol/L
Standard Deviation 7.72
|
-2.5 μmol/L
Standard Deviation 5.39
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 7
|
4.8 μmol/L
Standard Deviation 5.96
|
-5.0 μmol/L
Standard Deviation 5.37
|
-3.6 μmol/L
Standard Deviation 5.41
|
1.3 μmol/L
Standard Deviation 2.73
|
-5.7 μmol/L
Standard Deviation 7.45
|
-1.7 μmol/L
Standard Deviation 6.71
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 14
|
5.3 μmol/L
Standard Deviation 5.48
|
-7.0 μmol/L
Standard Deviation 9.41
|
-3.2 μmol/L
Standard Deviation 4.45
|
0.8 μmol/L
Standard Deviation 2.17
|
-1.0 μmol/L
Standard Deviation 6.16
|
-2.0 μmol/L
Standard Deviation 5.18
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 28
|
11.0 μmol/L
Standard Deviation 17.58
|
-0.3 μmol/L
Standard Deviation 15.47
|
-0.8 μmol/L
Standard Deviation 4.12
|
0.8 μmol/L
Standard Deviation 3.19
|
-5.3 μmol/L
Standard Deviation 8.85
|
-3.5 μmol/L
Standard Deviation 2.43
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Baseline (Day 1)
|
15.0 μmol/L
Standard Deviation 3.53
|
20.7 μmol/L
Standard Deviation 9.65
|
20.3 μmol/L
Standard Deviation 3.27
|
16.2 μmol/L
Standard Deviation 2.64
|
20.0 μmol/L
Standard Deviation 8.07
|
21.7 μmol/L
Standard Deviation 4.27
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 2
|
-0.8 μmol/L
Standard Deviation 1.32
|
2.3 μmol/L
Standard Deviation 9.03
|
-1.2 μmol/L
Standard Deviation 2.04
|
-1.8 μmol/L
Standard Deviation 1.83
|
-5.0 μmol/L
Standard Deviation 5.44
|
-3.3 μmol/L
Standard Deviation 4.84
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 3
|
0.3 μmol/L
Standard Deviation 2.54
|
0.3 μmol/L
Standard Deviation 6.35
|
-2.2 μmol/L
Standard Deviation 1.94
|
-2.2 μmol/L
Standard Deviation 2.64
|
-5.3 μmol/L
Standard Deviation 6.83
|
-3.8 μmol/L
Standard Deviation 4.31
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 5
|
0.2 μmol/L
Standard Deviation 2.44
|
-5.2 μmol/L
Standard Deviation 5.56
|
-1.8 μmol/L
Standard Deviation 0.75
|
-2.0 μmol/L
Standard Deviation 2.28
|
-5.2 μmol/L
Standard Deviation 6.88
|
-4.7 μmol/L
Standard Deviation 3.27
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Baseline (Day 1)
|
56.4 μmol/L
Standard Deviation 20.82
|
57.2 μmol/L
Standard Deviation 18.96
|
53.7 μmol/L
Standard Deviation 6.50
|
63.0 μmol/L
Standard Deviation 5.14
|
72.0 μmol/L
Standard Deviation 29.39
|
55.0 μmol/L
Standard Deviation 8.07
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 2
|
-4.1 μmol/L
Standard Deviation 6.35
|
-0.8 μmol/L
Standard Deviation 3.13
|
-2.5 μmol/L
Standard Deviation 3.27
|
-3.7 μmol/L
Standard Deviation 3.50
|
-4.2 μmol/L
Standard Deviation 7.41
|
-6.2 μmol/L
Standard Deviation 2.71
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 3
|
-3.3 μmol/L
Standard Deviation 6.00
|
-2.3 μmol/L
Standard Deviation 3.39
|
-3.0 μmol/L
Standard Deviation 5.06
|
-4.8 μmol/L
Standard Deviation 4.02
|
-5.7 μmol/L
Standard Deviation 9.37
|
-3.3 μmol/L
Standard Deviation 3.39
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 4
|
-1.9 μmol/L
Standard Deviation 7.74
|
-1.7 μmol/L
Standard Deviation 3.39
|
-1.2 μmol/L
Standard Deviation 5.19
|
2.0 μmol/L
Standard Deviation 6.39
|
-2.5 μmol/L
Standard Deviation 7.48
|
-2.3 μmol/L
Standard Deviation 2.73
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 5
|
-2.5 μmol/L
Standard Deviation 7.35
|
-3.2 μmol/L
Standard Deviation 4.07
|
-1.5 μmol/L
Standard Deviation 4.09
|
-0.8 μmol/L
Standard Deviation 5.98
|
-4.0 μmol/L
Standard Deviation 9.27
|
-2.0 μmol/L
Standard Deviation 3.46
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 6
|
-2.2 μmol/L
Standard Deviation 7.07
|
-3.8 μmol/L
Standard Deviation 3.54
|
-1.3 μmol/L
Standard Deviation 5.43
|
2.0 μmol/L
Standard Deviation 6.42
|
-4.5 μmol/L
Standard Deviation 12.88
|
-2.3 μmol/L
Standard Deviation 3.39
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 7
|
-1.8 μmol/L
Standard Deviation 8.01
|
-3.0 μmol/L
Standard Deviation 4.20
|
-3.2 μmol/L
Standard Deviation 4.32
|
2.0 μmol/L
Standard Deviation 6.63
|
-5.3 μmol/L
Standard Deviation 9.77
|
-1.0 μmol/L
Standard Deviation 3.16
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 14
|
0.4 μmol/L
Standard Deviation 5.77
|
0.8 μmol/L
Standard Deviation 8.58
|
-0.5 μmol/L
Standard Deviation 5.75
|
0.0 μmol/L
Standard Deviation 5.15
|
0.0 μmol/L
Standard Deviation 7.35
|
-1.8 μmol/L
Standard Deviation 3.13
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 21
|
2.1 μmol/L
Standard Deviation 12.14
|
0.0 μmol/L
Standard Deviation 4.90
|
-0.8 μmol/L
Standard Deviation 3.19
|
3.8 μmol/L
Standard Deviation 8.40
|
-1.8 μmol/L
Standard Deviation 11.48
|
-3.7 μmol/L
Standard Deviation 3.44
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 28
|
-0.3 μmol/L
Standard Deviation 7.06
|
1.8 μmol/L
Standard Deviation 3.87
|
2.0 μmol/L
Standard Deviation 8.72
|
5.5 μmol/L
Standard Deviation 8.48
|
-3.3 μmol/L
Standard Deviation 9.40
|
-3.5 μmol/L
Standard Deviation 3.56
|
|
Part 1: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Baseline (Day 1)
|
13.9 μmol/L
Standard Deviation 4.38
|
28.5 μmol/L
Standard Deviation 16.01
|
24.7 μmol/L
Standard Deviation 9.03
|
16.0 μmol/L
Standard Deviation 4.34
|
23.8 μmol/L
Standard Deviation 13.11
|
21.7 μmol/L
Standard Deviation 3.44
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 42Population: 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 received. Only those participants with data available at the specified timepoints were analyzed.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. 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-a-bottle (PiB)
n=7 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=8 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
10.5776 μmol/L
Standard Deviation 2.98545
|
10.0890 μmol/L
Standard Deviation 5.90780
|
9.5760 μmol/L
Standard Deviation 4.36923
|
12.8250 μmol/L
Standard Deviation 6.63163
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
0.1710 μmol/L
Standard Deviation 0.0000
|
—
|
0.5130 μmol/L
Standard Deviation 0.35400
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
1.3253 μmol/L
Standard Deviation 6.24774
|
3.6480 μmol/L
Standard Deviation 1.09582
|
—
|
2.9070 μmol/L
Standard Deviation 2.52478
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
-2.5308 μmol/L
Standard Deviation 5.31257
|
-1.9665 μmol/L
Standard Deviation 3.28525
|
-2.8856 μmol/L
Standard Deviation 2.53212
|
-4.5030 μmol/L
Standard Deviation 4.18257
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 12
|
-0.3420 μmol/L
Standard Deviation 0.0000
|
—
|
0.6840 μmol/L
Standard Deviation 0.48366
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
0.2565 μmol/L
Standard Deviation 1.04948
|
0.5700 μmol/L
Standard Deviation 0.42807
|
—
|
-0.0855 μmol/L
Standard Deviation 0.44262
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
0.1710 μmol/L
Standard Deviation 0.0000
|
—
|
0.8764 μmol/L
Standard Deviation 0.54412
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
0.4703 μmol/L
Standard Deviation 0.76950
|
0.3135 μmol/L
Standard Deviation 0.36542
|
—
|
0.7125 μmol/L
Standard Deviation 0.36542
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 8
|
-0.0855 μmol/L
Standard Deviation 0.12092
|
—
|
0.6413 μmol/L
Standard Deviation 0.60458
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 11
|
0.5130 μmol/L
Standard Deviation 0.91556
|
0.3990 μmol/L
Standard Deviation 0.31838
|
—
|
0.5700 μmol/L
Standard Deviation 0.46726
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
0.4703 μmol/L
Standard Deviation 0.66044
|
0.3990 μmol/L
Standard Deviation 0.36940
|
—
|
0.5130 μmol/L
Standard Deviation 0.30589
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 15
|
0.2565 μmol/L
Standard Deviation 0.12092
|
—
|
0.6413 μmol/L
Standard Deviation 0.42628
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
0.2993 μmol/L
Standard Deviation 0.78206
|
0.2280 μmol/L
Standard Deviation 0.46726
|
—
|
0.3420 μmol/L
Standard Deviation 0.35869
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 22
|
0.0855 μmol/L
Standard Deviation 0.12092
|
—
|
0.4703 μmol/L
Standard Deviation 0.53881
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
-0.2052 μmol/L
Standard Deviation 0.77800
|
-0.3705 μmol/L
Standard Deviation 0.52335
|
-0.3206 μmol/L
Standard Deviation 0.57401
|
-0.6840 μmol/L
Standard Deviation 0.71739
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 35
|
-0.2565 μmol/L
Standard Deviation 0.44262
|
-0.3135 μmol/L
Standard Deviation 0.61576
|
-0.2779 μmol/L
Standard Deviation 0.56298
|
0.3135 μmol/L
Standard Deviation 0.75253
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 42
|
-0.1710 μmol/L
Standard Deviation 0.37464
|
-0.6555 μmol/L
Standard Deviation 0.46412
|
0.1069 μmol/L
Standard Deviation 0.63942
|
0.0285 μmol/L
Standard Deviation 0.89456
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
2.0520 μmol/L
Standard Deviation 4.88623
|
3.5910 μmol/L
Standard Deviation 1.49466
|
—
|
4.0470 μmol/L
Standard Deviation 1.90622
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
0.4275 μmol/L
Standard Deviation 0.12092
|
—
|
2.9284 μmol/L
Standard Deviation 1.86301
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
-1.6245 μmol/L
Standard Deviation 0.36275
|
—
|
3.1421 μmol/L
Standard Deviation 2.90044
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
2.1375 μmol/L
Standard Deviation 5.96052
|
3.1350 μmol/L
Standard Deviation 2.20495
|
—
|
3.6195 μmol/L
Standard Deviation 1.75529
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 8
|
-1.7955 μmol/L
Standard Deviation 0.12092
|
—
|
3.5696 μmol/L
Standard Deviation 3.25149
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 11
|
2.0520 μmol/L
Standard Deviation 5.83575
|
3.7620 μmol/L
Standard Deviation 2.69508
|
—
|
3.6195 μmol/L
Standard Deviation 1.29517
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 12
|
-1.0260 μmol/L
Standard Deviation 1.20915
|
—
|
4.2964 μmol/L
Standard Deviation 2.74733
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
1.0688 μmol/L
Standard Deviation 4.14271
|
3.3345 μmol/L
Standard Deviation 1.83138
|
—
|
2.8215 μmol/L
Standard Deviation 1.26932
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 15
|
0.0855 μmol/L
Standard Deviation 1.08824
|
—
|
4.4033 μmol/L
Standard Deviation 2.53263
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
1.8383 μmol/L
Standard Deviation 3.83481
|
1.8810 μmol/L
Standard Deviation 3.11577
|
—
|
4.1325 μmol/L
Standard Deviation 2.32816
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 22
|
-0.5130 μmol/L
Standard Deviation 0.72549
|
—
|
2.6719 μmol/L
Standard Deviation 3.49125
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 35
|
-1.8525 μmol/L
Standard Deviation 3.35337
|
-1.8525 μmol/L
Standard Deviation 4.50534
|
-2.0306 μmol/L
Standard Deviation 2.42251
|
2.1945 μmol/L
Standard Deviation 4.64845
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 42
|
-1.2540 μmol/L
Standard Deviation 2.32376
|
-2.6505 μmol/L
Standard Deviation 4.28354
|
-0.9619 μmol/L
Standard Deviation 3.56231
|
0.2280 μmol/L
Standard Deviation 5.78644
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
1.6856 μmol/L
Standard Deviation 0.34805
|
1.7670 μmol/L
Standard Deviation 0.88304
|
1.6031 μmol/L
Standard Deviation 0.74782
|
2.5365 μmol/L
Standard Deviation 1.12089
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
0.1368 μmol/L
Standard Deviation 0.67756
|
0.1995 μmol/L
Standard Deviation 0.43820
|
—
|
0.3420 μmol/L
Standard Deviation 0.32445
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 42Population: 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 received. Only those participants with data available at the specified timepoints were analyzed.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD=0.00 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 0.00.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=7 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=8 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 11
|
-6.3 IU/L
Standard Deviation 6.02
|
-3.3 IU/L
Standard Deviation 3.67
|
—
|
-0.3 IU/L
Standard Deviation 5.47
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 35
|
-7.5 IU/L
Standard Deviation 7.79
|
3.5 IU/L
Standard Deviation 17.16
|
-3.5 IU/L
Standard Deviation 6.21
|
-4.8 IU/L
Standard Deviation 1.83
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 35
|
-1.2 IU/L
Standard Deviation 8.47
|
12.2 IU/L
Standard Deviation 25.97
|
-1.1 IU/L
Standard Deviation 4.26
|
-1.5 IU/L
Standard Deviation 4.51
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 8
|
-4.5 IU/L
Standard Deviation 2.12
|
—
|
-0.9 IU/L
Standard Deviation 4.29
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 28
|
-1.6 IU/L
Standard Deviation 3.13
|
0.2 IU/L
Standard Deviation 2.56
|
3.8 IU/L
Standard Deviation 9.08
|
3.0 IU/L
Standard Deviation 5.73
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 35
|
-0.8 IU/L
Standard Deviation 4.54
|
9.0 IU/L
Standard Deviation 19.07
|
1.6 IU/L
Standard Deviation 3.81
|
2.5 IU/L
Standard Deviation 5.96
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 12
|
-8.5 IU/L
Standard Deviation 2.12
|
—
|
-4.8 IU/L
Standard Deviation 7.19
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 14
|
-4.8 IU/L
Standard Deviation 5.85
|
-3.7 IU/L
Standard Deviation 4.46
|
—
|
-1.2 IU/L
Standard Deviation 3.66
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 15
|
-0.5 IU/L
Standard Deviation 6.36
|
—
|
-1.4 IU/L
Standard Deviation 8.85
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 5
|
-6.8 IU/L
Standard Deviation 14.31
|
2.7 IU/L
Standard Deviation 5.09
|
—
|
0.5 IU/L
Standard Deviation 2.59
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 21
|
-5.5 IU/L
Standard Deviation 4.65
|
-3.5 IU/L
Standard Deviation 4.04
|
—
|
-1.5 IU/L
Standard Deviation 5.47
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Baseline (Day 1)
|
56.0 IU/L
Standard Deviation 16.78
|
59.5 IU/L
Standard Deviation 19.69
|
69.0 IU/L
Standard Deviation 22.43
|
53.8 IU/L
Standard Deviation 10.55
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 2
|
-5.8 IU/L
Standard Deviation 12.48
|
-1.2 IU/L
Standard Deviation 3.92
|
—
|
-0.7 IU/L
Standard Deviation 3.50
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 3
|
0.0 IU/L
Standard Deviation 1.41
|
—
|
-0.4 IU/L
Standard Deviation 2.20
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 6
|
0.0 IU/L
Standard Deviation 1.41
|
—
|
0.3 IU/L
Standard Deviation 3.41
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 28
|
-3.4 IU/L
Standard Deviation 7.09
|
0.8 IU/L
Standard Deviation 3.66
|
1.4 IU/L
Standard Deviation 5.78
|
2.5 IU/L
Standard Deviation 8.46
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 7
|
-9.0 IU/L
Standard Deviation 14.31
|
-0.2 IU/L
Standard Deviation 3.66
|
—
|
0.3 IU/L
Standard Deviation 3.33
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 8
|
0.0 IU/L
Standard Deviation 1.41
|
—
|
2.9 IU/L
Standard Deviation 7.32
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 11
|
-9.0 IU/L
Standard Deviation 16.02
|
-5.5 IU/L
Standard Deviation 3.89
|
—
|
-2.7 IU/L
Standard Deviation 4.08
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 12
|
0.0 IU/L
Standard Deviation 1.41
|
—
|
-5.0 IU/L
Standard Deviation 3.34
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 14
|
-7.5 IU/L
Standard Deviation 15.15
|
1.5 IU/L
Standard Deviation 3.56
|
—
|
-4.2 IU/L
Standard Deviation 3.60
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 15
|
3.5 IU/L
Standard Deviation 3.54
|
—
|
-2.5 IU/L
Standard Deviation 3.70
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 21
|
-9.8 IU/L
Standard Deviation 15.59
|
-7.7 IU/L
Standard Deviation 6.44
|
—
|
-3.0 IU/L
Standard Deviation 4.82
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 22
|
0.0 IU/L
Standard Deviation 1.41
|
—
|
-5.3 IU/L
Standard Deviation 5.63
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 28
|
-6.2 IU/L
Standard Deviation 11.23
|
0.5 IU/L
Standard Deviation 9.52
|
-6.4 IU/L
Standard Deviation 4.96
|
-2.5 IU/L
Standard Deviation 3.15
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 42
|
-3.0 IU/L
Standard Deviation 7.48
|
0.8 IU/L
Standard Deviation 8.08
|
-2.5 IU/L
Standard Deviation 3.63
|
-0.3 IU/L
Standard Deviation 3.72
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Baseline (Day 1)
|
23.6 IU/L
Standard Deviation 8.30
|
15.8 IU/L
Standard Deviation 4.62
|
19.5 IU/L
Standard Deviation 5.71
|
19.8 IU/L
Standard Deviation 6.24
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 2
|
-2.6 IU/L
Standard Deviation 2.41
|
0.2 IU/L
Standard Deviation 1.72
|
—
|
-0.8 IU/L
Standard Deviation 2.32
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 3
|
-3.0 IU/L
Standard Deviation 1.41
|
—
|
-2.9 IU/L
Standard Deviation 3.56
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 5
|
-4.5 IU/L
Standard Deviation 4.20
|
0.2 IU/L
Standard Deviation 2.64
|
—
|
-2.5 IU/L
Standard Deviation 2.74
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 6
|
-7.0 IU/L
Standard Deviation 1.41
|
—
|
-3.9 IU/L
Standard Deviation 5.82
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 7
|
-5.5 IU/L
Standard Deviation 5.74
|
-1.3 IU/L
Standard Deviation 2.07
|
—
|
-1.0 IU/L
Standard Deviation 2.97
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 8
|
-6.0 IU/L
Standard Deviation 2.83
|
—
|
-1.4 IU/L
Standard Deviation 8.58
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 22
|
-7.0 IU/L
Standard Deviation 0.00
|
—
|
-2.5 IU/L
Standard Deviation 9.43
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 42
|
1.0 IU/L
Standard Deviation 8.39
|
-1.0 IU/L
Standard Deviation 4.29
|
1.0 IU/L
Standard Deviation 2.45
|
2.0 IU/L
Standard Deviation 4.10
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Baseline (Day 1)
|
23.3 IU/L
Standard Deviation 7.45
|
17.3 IU/L
Standard Deviation 3.44
|
18.9 IU/L
Standard Deviation 2.70
|
17.7 IU/L
Standard Deviation 3.27
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 2
|
-4.4 IU/L
Standard Deviation 5.81
|
-0.8 IU/L
Standard Deviation 1.47
|
—
|
-2.3 IU/L
Standard Deviation 2.25
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 3
|
-2.5 IU/L
Standard Deviation 0.71
|
—
|
-1.9 IU/L
Standard Deviation 2.23
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 5
|
-2.5 IU/L
Standard Deviation 1.00
|
-0.5 IU/L
Standard Deviation 1.87
|
—
|
-3.7 IU/L
Standard Deviation 2.73
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 6
|
-5.5 IU/L
Standard Deviation 0.71
|
—
|
-2.9 IU/L
Standard Deviation 3.14
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 7
|
-3.3 IU/L
Standard Deviation 1.89
|
-1.0 IU/L
Standard Deviation 2.10
|
—
|
-3.0 IU/L
Standard Deviation 2.45
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 11
|
-5.0 IU/L
Standard Deviation 3.16
|
-1.5 IU/L
Standard Deviation 1.64
|
—
|
-4.3 IU/L
Standard Deviation 3.01
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 12
|
-5.0 IU/L
Standard Deviation 2.83
|
—
|
-3.0 IU/L
Standard Deviation 2.45
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 14
|
-3.3 IU/L
Standard Deviation 2.22
|
-0.7 IU/L
Standard Deviation 2.73
|
—
|
-3.8 IU/L
Standard Deviation 2.32
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 15
|
-1.5 IU/L
Standard Deviation 2.12
|
—
|
-1.3 IU/L
Standard Deviation 3.81
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 21
|
-4.0 IU/L
Standard Deviation 1.83
|
-1.7 IU/L
Standard Deviation 2.25
|
—
|
-2.7 IU/L
Standard Deviation 3.83
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 22
|
-3.5 IU/L
Standard Deviation 3.54
|
—
|
-2.3 IU/L
Standard Deviation 3.20
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 42
|
0.8 IU/L
Standard Deviation 5.34
|
-1.0 IU/L
Standard Deviation 2.61
|
0.9 IU/L
Standard Deviation 3.44
|
3.0 IU/L
Standard Deviation 5.33
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 28Population: 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 received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of bilirubin. 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Baseline (Day 1)
|
1.4250 IU/L
Standard Deviation 0.69810
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 2
|
0.7125 IU/L
Standard Deviation 0.89456
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 3
|
0.8265 IU/L
Standard Deviation 0.93920
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 4
|
0.5415 IU/L
Standard Deviation 0.92667
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 5
|
0.4104 IU/L
Standard Deviation 0.53531
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 6
|
0.8835 IU/L
Standard Deviation 0.98182
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 7
|
0.5700 IU/L
Standard Deviation 0.79228
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 14
|
0.5415 IU/L
Standard Deviation 0.66154
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 21
|
0.4275 IU/L
Standard Deviation 0.41536
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Direct Bilirubin, Day 28
|
1.2540 IU/L
Standard Deviation 2.25219
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Baseline (Day 1)
|
7.6950 IU/L
Standard Deviation 3.19912
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 2
|
6.5550 IU/L
Standard Deviation 6.58354
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 3
|
6.1275 IU/L
Standard Deviation 6.16873
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 4
|
4.5600 IU/L
Standard Deviation 5.75401
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 5
|
3.6936 IU/L
Standard Deviation 3.29058
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 6
|
6.8970 IU/L
Standard Deviation 7.58181
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 7
|
3.5340 IU/L
Standard Deviation 5.11821
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 14
|
4.0755 IU/L
Standard Deviation 4.44786
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 21
|
0.5415 IU/L
Standard Deviation 2.47901
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: Direct Bilirubin, Total Bilirubin
Total Bilirubin, Day 28
|
6.7545 IU/L
Standard Deviation 13.42355
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) and up to Day 28Population: 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 received.
Blood samples were collected as assessed by protocol, at specific time points for laboratory analysis of ALT, ALP and AST. 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Baseline (Day 1)
|
52.0 IU/L
Standard Deviation 8.12
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 2
|
-1.3 IU/L
Standard Deviation 6.02
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 3
|
-1.0 IU/L
Standard Deviation 6.29
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 4
|
2.3 IU/L
Standard Deviation 6.31
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 5
|
5.4 IU/L
Standard Deviation 5.73
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 6
|
2.2 IU/L
Standard Deviation 6.52
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 7
|
2.7 IU/L
Standard Deviation 6.47
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 14
|
2.7 IU/L
Standard Deviation 7.17
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 21
|
0.7 IU/L
Standard Deviation 6.02
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALP, Day 28
|
4.3 IU/L
Standard Deviation 5.50
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Baseline (Day 1)
|
12.7 IU/L
Standard Deviation 4.03
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 2
|
2.5 IU/L
Standard Deviation 5.17
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 3
|
2.3 IU/L
Standard Deviation 5.57
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 4
|
2.3 IU/L
Standard Deviation 6.98
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 5
|
0.8 IU/L
Standard Deviation 1.64
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 6
|
2.5 IU/L
Standard Deviation 4.42
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 7
|
2.3 IU/L
Standard Deviation 3.39
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 14
|
4.8 IU/L
Standard Deviation 5.60
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 21
|
6.5 IU/L
Standard Deviation 6.66
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
ALT, Day 28
|
2.3 IU/L
Standard Deviation 1.03
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Baseline (Day 1)
|
16.7 IU/L
Standard Deviation 1.63
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 2
|
0.7 IU/L
Standard Deviation 3.50
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 3
|
-0.3 IU/L
Standard Deviation 2.34
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 4
|
-0.2 IU/L
Standard Deviation 2.64
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 5
|
-0.4 IU/L
Standard Deviation 1.52
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 6
|
0.5 IU/L
Standard Deviation 1.87
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 7
|
-0.3 IU/L
Standard Deviation 1.86
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 14
|
2.7 IU/L
Standard Deviation 3.27
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 21
|
4.3 IU/L
Standard Deviation 7.79
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Change From Baseline in Liver Panel Parameters: ALT, ALP and AST
AST, Day 28
|
1.8 IU/L
Standard Deviation 2.56
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The analysis was performed on the Safety Set which included all enrolled participants in Part 1 (SAD) who received at least 1 full or partial dose of study treatment. The participants were analyzed according to the treatment they 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-a-bottle (PiB)
n=10 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 Participants
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 1
|
0 Participants
|
2 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
|
|
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
|
2 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
|
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 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
|
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 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 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
Direct Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 42Population: 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 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-a-bottle (PiB)
n=7 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=8 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Parameters
ALT, Increase to Grade 1
|
0 Participants
|
1 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 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
|
0 Participants
|
1 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
AST, 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
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
|
1 Participants
|
—
|
—
|
|
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
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
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 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
|
—
|
—
|
|
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
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: 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 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
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
|
0 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
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 1
|
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 3
|
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 1
|
0 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
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
|
1 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 3
|
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 2
|
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
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the VH4011499 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 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinity (0-inf) Following Single Dose Administration of VH4011499
|
2759.51 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 53.69
|
8458.88 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 20.39
|
11627.63 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 36.01
|
24391.58 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 34.16
|
36327.28 Hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 48.29
|
—
|
PRIMARY outcome
Timeframe: At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB groupPopulation: The analysis was performed on the VH4011499 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=8 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499
Day 1/2
|
4211.67 h*ng/mL
Geometric Coefficient of Variation 15.36
|
5385.19 h*ng/mL
Geometric Coefficient of Variation 21.74
|
4879.14 h*ng/mL
Geometric Coefficient of Variation 36.00
|
—
|
—
|
—
|
|
Part 2: AUC Over a Dosing Interval From Time of Dosing to the Time of the Subsequent Dose (0-t) Following Repeat Dose Administration of VH4011499
Day 14/15
|
95735.06 h*ng/mL
Geometric Coefficient of Variation 56.77
|
168459.8 h*ng/mL
Geometric Coefficient of Variation 54.17
|
139259.6 h*ng/mL
Geometric Coefficient of Variation 24.66
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the VH4011499 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 Cmax.
Outcome measures
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of VH4011499.
|
26.85 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26.18
|
106.90 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17.24
|
168.88 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36.25
|
328.95 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 37.97
|
557.81 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.86
|
—
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the VH4011499 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) Following Single Dose Administration of VH4011499
|
11.30 hours
Geometric Coefficient of Variation 9.51
|
10.26 hours
Geometric Coefficient of Variation 14.77
|
9.28 hours
Geometric Coefficient of Variation 11.56
|
7.86 hours
Geometric Coefficient of Variation 22.83
|
8.79 hours
Geometric Coefficient of Variation 24.60
|
—
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the VH4011499 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 Participants
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 Participants
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 1: Apparent Terminal Half-life (T1/2) Following Single Dose Administration of VH4011499
|
63.97 hours
Geometric Coefficient of Variation 21.07
|
54.44 hours
Geometric Coefficient of Variation 23.86
|
61.61 hours
Geometric Coefficient of Variation 29.57
|
66.32 hours
Geometric Coefficient of Variation 24.75
|
55.90 hours
Geometric Coefficient of Variation 25.33
|
—
|
PRIMARY outcome
Timeframe: At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB groupPopulation: The analysis was performed on the VH4011499 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=8 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Cmax Following Repeat Dose Administration of VH4011499
Day 1
|
260.89 ng/mL
Geometric Coefficient of Variation 19.62
|
—
|
321.37 ng/mL
Geometric Coefficient of Variation 53.14
|
—
|
—
|
—
|
|
Part 2: Cmax Following Repeat Dose Administration of VH4011499
Day 2
|
—
|
348.24 ng/mL
Geometric Coefficient of Variation 20.46
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax Following Repeat Dose Administration of VH4011499
Day 14
|
1272.25 ng/mL
Geometric Coefficient of Variation 42.47
|
—
|
1509.90 ng/mL
Geometric Coefficient of Variation 22.56
|
—
|
—
|
—
|
|
Part 2: Cmax Following Repeat Dose Administration of VH4011499
Day 15
|
—
|
1913.76 ng/mL
Geometric Coefficient of Variation 22.93
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Days 1 and 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Days 2 and 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB groupPopulation: The analysis was performed on the VH4011499 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=8 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: Tmax Following Repeat Dose Administration of VH4011499
Day 1
|
10.71 hours
Geometric Coefficient of Variation 41.53
|
—
|
9.50 hours
Geometric Coefficient of Variation 51.00
|
—
|
—
|
—
|
|
Part 2: Tmax Following Repeat Dose Administration of VH4011499
Day 2
|
—
|
8.11 hours
Geometric Coefficient of Variation 22.96
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax Following Repeat Dose Administration of VH4011499
Day 14
|
4.80 hours
Geometric Coefficient of Variation 30.46
|
—
|
5.99 hours
Geometric Coefficient of Variation 42.79
|
—
|
—
|
—
|
|
Part 2: Tmax Following Repeat Dose Administration of VH4011499
Day 15
|
—
|
5.27 hours
Geometric Coefficient of Variation 32.11
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 14 for Part 2 (MAD): VH4011499 200 mg PiB and Part 2 (MAD): VH4011499 400 mg PiB groups, and at Day 15 for Part 2 (MAD): VH4011499 300 mg + Midazolam PiB groupPopulation: The analysis was performed on the VH4011499 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-a-bottle (PiB)
n=6 Participants
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=8 Participants
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 Participants
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|
|
Part 2: T1/2 Following Repeat Dose Administration of VH4011499
Day 14
|
51.17 hours
Geometric Coefficient of Variation 16.68
|
—
|
60.36 hours
Geometric Coefficient of Variation 21.81
|
—
|
—
|
—
|
|
Part 2: T1/2 Following Repeat Dose Administration of VH4011499
Day 15
|
—
|
66.47 hours
Geometric Coefficient of Variation 19.10
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 (SAD): VH4011499 25 mg PiB
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 (SAD): VH4011499 125 mg PiB
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 (SAD): VH4011499 200 mg PiB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 (SAD): VH4011499 625 mg PiB
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 (SAD): VH4011499 1875 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: 2 other events
Deaths: 0 deaths
Part 2 (MAD): VH4011499 200 mg PiB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 (MAD): VH4011499 400 mg PiB
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 3 (Single Dose): VH4011499 200 mg Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=10 participants at risk
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
n=7 participants at risk
Healthy participants were given a dose of placebo once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 200 mg PiB
n=6 participants at risk
Healthy participants were given a dose of VH4011499 200 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB
n=8 participants at risk
Healthy participants were given a dose of VH4011499 300 mg once daily and a single dose of Midazolam on Days 1, 2, and 15, and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 400 mg PiB
n=6 participants at risk
Healthy participants were given a dose of VH4011499 400 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 3 (Single Dose): VH4011499 200 mg Tablet
n=6 participants at risk
Healthy participants were given a dose of VH4011499 200 mg tablet on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
Other adverse events
| Measure |
Part 1 Single Ascending Dose (SAD): Placebo Powder-in-a-bottle (PiB)
n=10 participants at risk
Healthy participants were given a single dose of placebo on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 25 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 25 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 125 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 125 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 200 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 200 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 625 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 625 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 1 (SAD): VH4011499 1875 mg PiB
n=6 participants at risk
Healthy participants were given a single dose of 1875 mg VH4011499 on Day 1 and were followed up until Day 28.
|
Part 2 Multiple Ascending Dose (MAD): Placebo PiB
n=7 participants at risk
Healthy participants were given a dose of placebo once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 200 mg PiB
n=6 participants at risk
Healthy participants were given a dose of VH4011499 200 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 300 mg + Midazolam (MDZ) PiB
n=8 participants at risk
Healthy participants were given a dose of VH4011499 300 mg once daily and a single dose of Midazolam on Days 1, 2, and 15, and were followed up until Day 42.
|
Part 2 (MAD): VH4011499 400 mg PiB
n=6 participants at risk
Healthy participants were given a dose of VH4011499 400 mg PiB once daily for a 14-day period and were followed up until Day 42.
|
Part 3 (Single Dose): VH4011499 200 mg Tablet
n=6 participants at risk
Healthy participants were given a dose of VH4011499 200 mg tablet on Day 1 and were followed up until Day 28.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Infrequent bowel movements
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Toothache
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Vomiting
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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 3 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Feeling abnormal
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Medical device site dermatitis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Gastroenteritis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Skin abrasion
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Activated partial thromboplastin time prolonged
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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 triglycerides increased
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Haematocrit decreased
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Haemoglobin decreased
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Total bile acids increased
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Back pain
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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 3 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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 3 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Presyncope
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Somnolence
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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 3 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Psychiatric disorders
Depressed mood
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Epistaxis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Dry skin
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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
Pruritus
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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 pain
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
The analysis was performed on the Safety Set which included all participants who received at least 1 full or partial dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • All-cause mortality, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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, non-serious adverse events and serious adverse events were collected up to 28-days following final dose of VH4011499 or placebo (Day 28 for Part 1 and Part 3, and Day 42 for Part 2).
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