Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Investigation of GSK3335065 Intravenous (IV) Infusion in Healthy Adults (NCT NCT03245619)
NCT ID: NCT03245619
Last Updated: 2020-06-16
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. All Subject Population comprised of all participants randomized to treatment who received at least one dose of study treatment. AEs and SAEs were collected from admission until follow-up. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Up to Day 22
Results posted on
2020-06-16
Participant Flow
This was planned to be a 3 part, dose escalation study; however, the study was terminated during Part A (Cohort 3) because a relationship between GSK3335065 and ventricular tachycardia in a participant could not be excluded. Hence, participants were not recruited in Cohorts 4 to 8 of Part A; Part B and Part C were not initiated.
A total of 55 participants were screened of which 33 failed screening and 4 were kept in reserve but not used. A total of 18 participants were enrolled in the study. The study was conducted in the United Kingdom. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Participant milestones
| Measure |
Part A: Placebo
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
Part B: Placebo
Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
|
Part B-Cohort 9: 0.14 mg IV Bolus+0.012 mg/Hour IV Infusion
Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.012 mg/hour for 7 days.
|
Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
|
Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
|
Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
|
Part C: Placebo
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
|
Part C-Cohort 13: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
|
Part C-Cohort 14: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part A (Up to Day 22)
STARTED
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5
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6
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6
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1
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0
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0
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Part A (Up to Day 22)
COMPLETED
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1
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0
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0
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1
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Part A (Up to Day 22)
NOT COMPLETED
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4
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6
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Part B (Up to 34 Days)
STARTED
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Part B (Up to 34 Days)
COMPLETED
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Part B (Up to 34 Days)
NOT COMPLETED
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Part C (Up to 34 Days)
STARTED
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Part C (Up to 34 Days)
COMPLETED
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0
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Part C (Up to 34 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Part A: Placebo
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
Part B: Placebo
Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
|
Part B-Cohort 9: 0.14 mg IV Bolus+0.012 mg/Hour IV Infusion
Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.012 mg/hour for 7 days.
|
Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
|
Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
|
Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
|
Part C: Placebo
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
|
Part C-Cohort 13: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
|
Part C-Cohort 14: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (Up to Day 22)
Physician Decision
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4
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6
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6
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Baseline Characteristics
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Investigation of GSK3335065 Intravenous (IV) Infusion in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=5 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
Part B: Placebo
Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
|
Part B-Cohort 9: 0.14 mg IV Bolus+0.012 mg/Hour IV Infusion
Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.012 mg/hour for 7 days.
|
Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
|
Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
|
Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
|
Part C: Placebo
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
|
Part C-Cohort 13: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
|
Part C-Cohort 14: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.8 Years
STANDARD_DEVIATION 5.97 • n=99 Participants
|
35.8 Years
STANDARD_DEVIATION 11.81 • n=107 Participants
|
43.2 Years
STANDARD_DEVIATION 7.57 • n=206 Participants
|
47.0 Years
STANDARD_DEVIATION NA • n=7 Participants
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
40.6 Years
STANDARD_DEVIATION 8.91 • n=102 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
18 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
17 Participants
n=102 Participants
|
PRIMARY outcome
Timeframe: Up to Day 22Population: All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. All Subject Population comprised of all participants randomized to treatment who received at least one dose of study treatment. AEs and SAEs were collected from admission until follow-up. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A
Any AE
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. AEs and SAEs were planned to be collected from admission until follow-up.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. AEs and SAEs were planned to be collected from admission until follow-up.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 22Population: All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8x10\^9 cells per liter \[cells/L\]); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). Data for worst-case post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Hemoglobin; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Hemoglobin; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Hematocrit; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Hematocrit; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Lymphocytes; Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Lymphocytes; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Neutrophils; Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Neutrophils; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Platelet count; Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Platelet count; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
Platelet count; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
White blood cell count; Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
White blood cell count; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A
White blood cell count; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples were planned to be collected for the assessment of hematology parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples were planned to be collected for the assessment of hematology parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 22Population: All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 millimoles per liter \[mmol/L\]); alanine aminotransferase (ALT) (high: \>=2xupper limit of normal \[ULN\]); aspartate aminotransferase (AST) (high: \>=2xULN); alkaline phosphatase (ALP) (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for worst-case post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Albumin; Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Albumin; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
ALP; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
ALP; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
ALT; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
ALT; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
AST; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
AST; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Total bilirubin; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Total bilirubin; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Calcium; Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Calcium; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Calcium; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Glucose; Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Glucose; Normal
|
5 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Glucose; High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Potassium; Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Potassium; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Potassium; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Sodium; Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Sodium; Normal
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A
Sodium; High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples were planned to be collected for the assessment of clinical chemistry parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples were planned to be collected for the assessment of clinical chemistry parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 22Population: All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Urine samples were taken for the assessment of following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Microscopic examination was performed and collected for any abnormal dipstick results. Number of participants with abnormal urine parameters any time post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urine Parameters-Part A
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.
Urine samples were planned to be collected for the assessment of urine parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.
Urine samples were planned to be collected for the assessment of urine parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 22Population: All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, QT interval corrected using Fridericia's formula (QTcF) and Bazett's QT interval corrected for heart rate (QTcB). ECG measurements were preceded by at least 5 minutes rest for the participant in a semi-recumbent position. Number of participants with abnormal-clinically significant and abnormal-not clinically significant ECG findings at worst case post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A
Abnormal-clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A
Abnormal-not clinically significant
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.
Triplicate 12-lead ECGs were planned to be obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, QTcF and QTcB intervals.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.
Triplicate 12-lead ECGs were planned to be obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, QTcF and QTcB intervals.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 22Population: All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, respiration rate and temperature were measured in a semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Participants are counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Data for worst case post-Baseline relative to Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs-Part A
DBP; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
DBP; To Normal or no change
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Heart rate; To Normal or no change
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
DBP; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
SBP; To Low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
SBP; To Normal or no change
|
4 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
SBP; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Heart rate; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Heart rate; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Respiration rate; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Respiration rate; To Normal or no change
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Respiration rate; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Temperature; To Low
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Temperature; To Normal or no change
|
1 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs-Part A
Temperature; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.
Vital signs including SBP, DBP, heart rate, respiration rate and temperature were planned to be measured in a semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 34Population: All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.
Vital signs including SBP, DBP, heart rate, respiration rate and temperature were planned to be measured in a semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: PK Parameter Population
Blood samples for pharmacokinetic (PK) analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. PK Parameter Population comprised of all active participants whose PK sample was obtained and analyzed and who provided PK parameters.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration (AUC[0-t]) for GSK3335065-Part A (Cohorts 1 and 2)
|
14.1222 Hours*nanograms per milliliter
Geometric Coefficient of Variation 576.3
|
201.1366 Hours*nanograms per milliliter
Geometric Coefficient of Variation 30.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t) for GSK3335065-Part A (Cohorts 3 to 8)
|
2701.9080 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: PK Parameter Population. Only participants with PK parameters that could be derived are summarized.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=4 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-Inf]) for GSK3335065-Part A (Cohorts 1 and 2)
|
51.68 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed at the specified time point.
|
310.46 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-Inf) for GSK3335065-Part A (Cohorts 3 to 8)
|
2811.51 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: PK Parameter Population
Blood samples for pharmacokinetic PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time of the Last Measurable Concentration (Tlast) of GSK3335065-Part A (Cohorts 1 and 2)
|
9.0006 Hours
Interval 0.333 to 71.7
|
72.0250 Hours
Interval 72.0 to 72.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Tlast of GSK3335065-Part A (Cohorts 3 to 8)
|
168.0000 Hours
Interval 168.0 to 168.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: PK Parameter Population
Blood samples for pharmacokinetic PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of GSK3335065-Part A (Cohorts 1 and 2)
|
10.018 Nanograms per milliliter
Geometric Coefficient of Variation 145.8
|
14.254 Nanograms per milliliter
Geometric Coefficient of Variation 37.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax of GSK3335065-Part A (Cohorts 3 to 8)
|
169.090 Nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: PK Parameter Population
Blood samples for pharmacokinetic PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) for GSK3335065-Part A (Cohorts 1 and 2)
|
0.2050 Hours
Interval 0.2 to 0.5
|
0.2061 Hours
Interval 0.2 to 0.217
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Tmax of GSK3335065-Part A (Cohorts 3 to 8)
|
0.2000 Hours
Interval 0.2 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: PK Parameter Population. Only participants with PK parameters that could be derived are summarized.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=4 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clearance for GSK3335065-Part A (Cohorts 1 and 2)
|
1.9349 Liters per hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed.
|
0.8053 Liters per hour
Geometric Coefficient of Variation 26.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clearance for GSK3335065-Part A (Cohorts 3 to 8)
|
0.4624 Liters per hour
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: PK Parameter Population. Only participants with PK parameters that could be derived are summarized.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=4 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution for GSK3335065-Part A (Cohorts 1 and 2)
|
2.074 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed.
|
44.642 Liters
Geometric Coefficient of Variation 43.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution for GSK3335065-Part A (Cohorts 3 to 8)
|
20.574 Liters
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: PK Parameter Population. Only participants with PK parameters that could be derived are summarized.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=4 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half Life (T1/2) for GSK3335065-Part A (Cohorts 1 and 2)
|
0.515 Hours
Interval 0.515 to 0.515
|
34.4957 Hours
Interval 31.458 to 49.278
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.
Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
T1/2 for GSK3335065-Part A (Cohorts 3 to 8)
|
31.265 Hours
Interval 31.265 to 31.265
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)Population: PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6, 15 and 30 minutes, 1, 1.5, 2, 3, 4.5, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dosePopulation: All Subject Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). Data was not collected for placebo arms of Cohorts 1 and 2.
Blood samples were collected to measure the kynurenine-3-monooxygenase (KMO) enzyme inhibition by determining the levels of the biomarkers Kynurenine (Kyn) and 3-hydroxykynurenine (3-HK). Baseline was the average of all pre-dose measurements (Day 1 \[pre-dose at 1 hour and 30 minutes\]). Change from Baseline was calculated as value at the specified time point minus the Baseline value.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 6 minutes, n=6, 6,0,0
|
-0.5268 Arbitrary units
Interval -3.424 to 5.256
|
-1.5010 Arbitrary units
Interval -4.173 to 0.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 15 minutes, n=5, 6,0,0
|
-0.9925 Arbitrary units
Interval -10.193 to 2.797
|
-2.0095 Arbitrary units
Interval -13.189 to 0.662
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 30 minutes, n=6, 6,0,0
|
-0.1905 Arbitrary units
Interval -3.042 to 0.913
|
-4.0610 Arbitrary units
Interval -8.311 to -2.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 1 hour, n=6, 6,0,0
|
-0.9763 Arbitrary units
Interval -9.01 to 0.786
|
-4.8000 Arbitrary units
Interval -53.661 to 0.082
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 1.5 hours, n=5, 6,0,0
|
0.1825 Arbitrary units
Interval -7.525 to 0.771
|
-3.7645 Arbitrary units
Interval -53.469 to 0.824
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 2 hours, n=6, 6,0,0
|
-0.6308 Arbitrary units
Interval -16.142 to -0.428
|
-2.9960 Arbitrary units
Interval -53.131 to 0.603
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 3 hours, n=6, 6,0,0
|
-1.2058 Arbitrary units
Interval -23.589 to -0.564
|
-5.1320 Arbitrary units
Interval -54.303 to 1.208
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 4.5 hours, n=6, 6,0,0
|
-1.4485 Arbitrary units
Interval -16.9 to 0.63
|
-1.6475 Arbitrary units
Interval -52.847 to 0.455
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 6 hours, n=6, 6,0,0
|
-0.8595 Arbitrary units
Interval -14.023 to 0.955
|
-1.1470 Arbitrary units
Interval -54.156 to 0.656
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 9 hours, n=6, 6,0,0
|
-0.3513 Arbitrary units
Interval -15.815 to 7.477
|
-1.4675 Arbitrary units
Interval -52.799 to -0.527
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 12 hours, n=6, 5,0,0
|
0.2715 Arbitrary units
Interval -11.93 to 2.69
|
-6.7390 Arbitrary units
Interval -51.888 to 1.161
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 15 hours, n=6, 6,0,0
|
-0.0638 Arbitrary units
Interval -7.953 to 8.618
|
-6.3450 Arbitrary units
Interval -51.817 to 3.678
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 18 hours, n=6, 6,0,0
|
0.5473 Arbitrary units
Interval -0.393 to 9.068
|
-7.0860 Arbitrary units
Interval -50.969 to 3.649
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 24 hours, n=5, 6,0,0
|
1.0925 Arbitrary units
Interval -0.482 to 30.033
|
-6.2475 Arbitrary units
Interval -52.873 to 3.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 30 hours, n=6, 6,0,0
|
8.0473 Arbitrary units
Interval -0.992 to 53.074
|
-6.3505 Arbitrary units
Interval -52.427 to 6.049
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 36 hours, n=6, 6,0,0
|
5.3745 Arbitrary units
Interval -0.669 to 29.479
|
-7.8850 Arbitrary units
Interval -53.757 to -1.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 42 hours, n=6, 6,0,0
|
9.3905 Arbitrary units
Interval -1.433 to 38.095
|
-7.6030 Arbitrary units
Interval -53.889 to -2.744
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 48 hours, n=5, 6,0,0
|
2.0095 Arbitrary units
Interval -0.369 to 61.652
|
-7.1525 Arbitrary units
Interval -53.577 to -0.986
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 60 hours, n=6, 6,0,0
|
17.0725 Arbitrary units
Interval -0.122 to 65.258
|
-6.8810 Arbitrary units
Interval -48.751 to -2.491
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
3-HK, 72 hours, n=5, 6,0,0
|
2.7515 Arbitrary units
Interval -0.23 to 82.21
|
-6.9270 Arbitrary units
Interval -53.175 to 0.097
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 6 minutes, n=6, 6,0,0
|
-11.163 Arbitrary units
Interval -152.3 to 122.87
|
-84.808 Arbitrary units
Interval -190.62 to 26.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 15 minutes, n=6, 6,0,0
|
-5.635 Arbitrary units
Interval -97.53 to 142.32
|
-62.958 Arbitrary units
Interval -242.02 to 54.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 30 minutes, n=6, 5,0,0
|
71.833 Arbitrary units
Interval -26.27 to 282.72
|
-133.385 Arbitrary units
Interval -189.31 to -3.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 1 hour, n=6, 5,0,0
|
12.555 Arbitrary units
Interval -58.4 to 85.2
|
-177.145 Arbitrary units
Interval -326.12 to 156.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 1.5 hours, n=6, 6,0,0
|
56.643 Arbitrary units
Interval -49.59 to 208.52
|
-11.232 Arbitrary units
Interval -330.43 to 268.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 2 hours, n=6, 6,0,0
|
32.290 Arbitrary units
Interval -127.79 to 752.12
|
-12.068 Arbitrary units
Interval -342.19 to 300.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 3 hours, n=6, 6,0,0
|
8.270 Arbitrary units
Interval -112.74 to 175.03
|
-26.503 Arbitrary units
Interval -217.56 to 322.93
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 4.5 hours, n=6, 6,0,0
|
-64.150 Arbitrary units
Interval -299.63 to 82.56
|
20.593 Arbitrary units
Interval -267.84 to 217.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 6 hours, n=6, 5,0,0
|
-64.575 Arbitrary units
Interval -116.56 to 39.07
|
-60.595 Arbitrary units
Interval -226.92 to 62.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 9 hours, n=6, 6,0,0
|
-70.120 Arbitrary units
Interval -142.45 to 37.49
|
-20.343 Arbitrary units
Interval -182.12 to 104.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 12 hours, n=6, 5,0,0
|
-67.010 Arbitrary units
Interval -212.82 to 5.69
|
-73.645 Arbitrary units
Interval -249.04 to 98.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 15 hours, n=6, 6,0,0
|
-44.860 Arbitrary units
Interval -183.49 to 1.43
|
49.052 Arbitrary units
Interval -176.83 to 293.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 18 hours, n=6, 6,0,0
|
-19.000 Arbitrary units
Interval -116.91 to 27.75
|
-20.368 Arbitrary units
Interval -249.38 to 317.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 24 hours, n=6, 6,0,0
|
56.217 Arbitrary units
Interval -322.14 to 265.51
|
30.267 Arbitrary units
Interval -145.39 to 302.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 30 hours, n=6, 6,0,0
|
-31.158 Arbitrary units
Interval -372.49 to 221.45
|
20.302 Arbitrary units
Interval -280.86 to 185.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 36 hours, n=6, 5,0,0
|
7.397 Arbitrary units
Interval -440.47 to 238.01
|
56.970 Arbitrary units
Interval -265.3 to 289.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 42 hours, n=6, 6,0,0
|
20.538 Arbitrary units
Interval -430.69 to 356.89
|
15.815 Arbitrary units
Interval -250.52 to 200.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 48 hours, n=6, 6,0,0
|
-7.700 Arbitrary units
Interval -150.9 to 90.51
|
49.802 Arbitrary units
Interval -279.51 to 181.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 60 hours, n=6, 5,0,0
|
-104.425 Arbitrary units
Interval -273.75 to 23.96
|
25.040 Arbitrary units
Interval -208.52 to 406.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)
Kyn, 72 hours, n=6, 6,0,0
|
58.737 Arbitrary units
Interval -436.82 to 339.54
|
90.590 Arbitrary units
Interval -155.63 to 272.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6, 15 and 30 minutes, 1, 1.5, 2, 3, 4.5, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dosePopulation: All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure the KMO enzyme inhibition by determining the levels of the biomarkers Kyn and 3-HK. Baseline was the average of all pre-dose measurements (Day -1 \[pre-dose at 16 hours, 14 hours, 12 hours and 10 hours\] and Day 1 \[pre-dose at 30 minutes and 2 hours\]). Change from Baseline was calculated as value at the specified time point minus the Baseline value.
Outcome measures
| Measure |
Part A: Placebo
n=1 Participants
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=1 Participants
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 6 minutes
|
0.049 Arbitrary units
Interval 0.049 to 0.049
|
0.133 Arbitrary units
Interval 0.133 to 0.133
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 15 minutes
|
0.233 Arbitrary units
Interval 0.233 to 0.233
|
0.025 Arbitrary units
Interval 0.025 to 0.025
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 30 minutes
|
0.168 Arbitrary units
Interval 0.168 to 0.168
|
-0.823 Arbitrary units
Interval -0.823 to -0.823
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 1 hour
|
-0.351 Arbitrary units
Interval -0.351 to -0.351
|
-0.784 Arbitrary units
Interval -0.784 to -0.784
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 1.5 hours
|
-0.380 Arbitrary units
Interval -0.38 to -0.38
|
-0.337 Arbitrary units
Interval -0.337 to -0.337
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 2 hours
|
-0.396 Arbitrary units
Interval -0.396 to -0.396
|
-0.255 Arbitrary units
Interval -0.255 to -0.255
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 3 hours
|
-0.058 Arbitrary units
Interval -0.058 to -0.058
|
-0.378 Arbitrary units
Interval -0.378 to -0.378
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 4.5 hours
|
-0.581 Arbitrary units
Interval -0.581 to -0.581
|
-0.339 Arbitrary units
Interval -0.339 to -0.339
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 6 hours
|
0.164 Arbitrary units
Interval 0.164 to 0.164
|
-0.304 Arbitrary units
Interval -0.304 to -0.304
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 9 hours
|
0.607 Arbitrary units
Interval 0.607 to 0.607
|
-0.935 Arbitrary units
Interval -0.935 to -0.935
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 12 hours
|
0.070 Arbitrary units
Interval 0.07 to 0.07
|
-0.495 Arbitrary units
Interval -0.495 to -0.495
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 15 hour
|
0.076 Arbitrary units
Interval 0.076 to 0.076
|
-0.220 Arbitrary units
Interval -0.22 to -0.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 18 hours
|
0.101 Arbitrary units
Interval 0.101 to 0.101
|
-0.231 Arbitrary units
Interval -0.231 to -0.231
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 24 hours
|
-0.088 Arbitrary units
Interval -0.088 to -0.088
|
-0.149 Arbitrary units
Interval -0.149 to -0.149
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 30 hours
|
0.178 Arbitrary units
Interval 0.178 to 0.178
|
-0.284 Arbitrary units
Interval -0.284 to -0.284
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 36 hours
|
-0.039 Arbitrary units
Interval -0.039 to -0.039
|
-0.172 Arbitrary units
Interval -0.172 to -0.172
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 42 hours
|
0.206 Arbitrary units
Interval 0.206 to 0.206
|
-0.035 Arbitrary units
Interval -0.035 to -0.035
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 48 hours
|
0.331 Arbitrary units
Interval 0.331 to 0.331
|
0.004 Arbitrary units
Interval 0.004 to 0.004
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 60 hours
|
0.004 Arbitrary units
Interval 0.004 to 0.004
|
-0.090 Arbitrary units
Interval -0.09 to -0.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 72 hours
|
0.496 Arbitrary units
Interval 0.496 to 0.496
|
0.397 Arbitrary units
Interval 0.397 to 0.397
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 84 hour
|
0.146 Arbitrary units
Interval 0.146 to 0.146
|
-0.002 Arbitrary units
Interval -0.002 to -0.002
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 96 hours
|
0.402 Arbitrary units
Interval 0.402 to 0.402
|
0.418 Arbitrary units
Interval 0.418 to 0.418
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 108 hours
|
—
|
-0.122 Arbitrary units
Interval -0.122 to -0.122
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 120 hours
|
0.318 Arbitrary units
Interval 0.318 to 0.318
|
0.682 Arbitrary units
Interval 0.682 to 0.682
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 132 hours
|
-0.231 Arbitrary units
Interval -0.231 to -0.231
|
-0.488 Arbitrary units
Interval -0.488 to -0.488
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 144 hours
|
0.381 Arbitrary units
Interval 0.381 to 0.381
|
0.301 Arbitrary units
Interval 0.301 to 0.301
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 156 hours
|
-0.024 Arbitrary units
Interval -0.024 to -0.024
|
0.413 Arbitrary units
Interval 0.413 to 0.413
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
3HK, 168 hours
|
0.203 Arbitrary units
Interval 0.203 to 0.203
|
1.442 Arbitrary units
Interval 1.442 to 1.442
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 6 minutes
|
32.77 Arbitrary units
Interval 32.77 to 32.77
|
60.96 Arbitrary units
Interval 60.96 to 60.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 15 minutes
|
23.51 Arbitrary units
Interval 23.51 to 23.51
|
109.14 Arbitrary units
Interval 109.14 to 109.14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 30 minutes
|
29.63 Arbitrary units
Interval 29.63 to 29.63
|
175.50 Arbitrary units
Interval 175.5 to 175.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 1 hour
|
-11.97 Arbitrary units
Interval -11.97 to -11.97
|
51.83 Arbitrary units
Interval 51.83 to 51.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 1.5 hours
|
-11.29 Arbitrary units
Interval -11.29 to -11.29
|
256.80 Arbitrary units
Interval 256.8 to 256.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 2 hours
|
-63.46 Arbitrary units
Interval -63.46 to -63.46
|
238.54 Arbitrary units
Interval 238.54 to 238.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 3 hours
|
121.88 Arbitrary units
Interval 121.88 to 121.88
|
296.10 Arbitrary units
Interval 296.1 to 296.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 4.5 hours
|
9.92 Arbitrary units
Interval 9.92 to 9.92
|
251.86 Arbitrary units
Interval 251.86 to 251.86
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 6 hours
|
-3.33 Arbitrary units
Interval -3.33 to -3.33
|
357.65 Arbitrary units
Interval 357.65 to 357.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 9 hours
|
34.10 Arbitrary units
Interval 34.1 to 34.1
|
-97.16 Arbitrary units
Interval -97.16 to -97.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 12 hours
|
15.83 Arbitrary units
Interval 15.83 to 15.83
|
19.56 Arbitrary units
Interval 19.56 to 19.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 15 hours
|
23.38 Arbitrary units
Interval 23.38 to 23.38
|
220.24 Arbitrary units
Interval 220.24 to 220.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 18 hours
|
15.01 Arbitrary units
Interval 15.01 to 15.01
|
200.28 Arbitrary units
Interval 200.28 to 200.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 24 hours
|
6.46 Arbitrary units
Interval 6.46 to 6.46
|
270.82 Arbitrary units
Interval 270.82 to 270.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 30 hours
|
3.36 Arbitrary units
Interval 3.36 to 3.36
|
250.63 Arbitrary units
Interval 250.63 to 250.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 36 hours
|
69.66 Arbitrary units
Interval 69.66 to 69.66
|
242.45 Arbitrary units
Interval 242.45 to 242.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 42 hours
|
44.27 Arbitrary units
Interval 44.27 to 44.27
|
181.50 Arbitrary units
Interval 181.5 to 181.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 48 hours
|
45.83 Arbitrary units
Interval 45.83 to 45.83
|
185.08 Arbitrary units
Interval 185.08 to 185.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 60 hours
|
18.48 Arbitrary units
Interval 18.48 to 18.48
|
133.60 Arbitrary units
Interval 133.6 to 133.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 72 hours
|
47.49 Arbitrary units
Interval 47.49 to 47.49
|
148.38 Arbitrary units
Interval 148.38 to 148.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 84 hours
|
11.04 Arbitrary units
Interval 11.04 to 11.04
|
102.65 Arbitrary units
Interval 102.65 to 102.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 96 hours
|
30.42 Arbitrary units
Interval 30.42 to 30.42
|
116.33 Arbitrary units
Interval 116.33 to 116.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 108 hours
|
—
|
1.09 Arbitrary units
Interval 1.09 to 1.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 120 hours
|
39.15 Arbitrary units
Interval 39.15 to 39.15
|
114.69 Arbitrary units
Interval 114.69 to 114.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 132 hours
|
-63.46 Arbitrary units
Interval -63.46 to -63.46
|
46.58 Arbitrary units
Interval 46.58 to 46.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 144 hours
|
27.70 Arbitrary units
Interval 27.7 to 27.7
|
138.24 Arbitrary units
Interval 138.24 to 138.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 156 hours
|
16.46 Arbitrary units
Interval 16.46 to 16.46
|
89.25 Arbitrary units
Interval 89.25 to 89.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)
Kyn, 168 hours
|
18.94 Arbitrary units
Interval 18.94 to 18.94
|
73.34 Arbitrary units
Interval 73.34 to 73.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18 hours post-infusion), Days2 to 7 (pre-dose), Day8 (6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 hours post-infusion)Population: All Subject Population. Data was not collected as no participants were enrolled in Part B of the study.
Blood samples were planned to be collected to measure the KMO enzyme inhibition by determining the levels of the biomarkers Kyn and 3-HK.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18 hours post-infusion), Days2 to 7 (pre-dose), Day8 (6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 hours post-infusion)Population: All Subject Population. Data was not collected as no participants were enrolled in Part C of the study.
Blood samples were planned to be collected to measure the KMO enzyme inhibition by determining the levels of the biomarkers Kyn and 3-HK.
Outcome measures
Outcome data not reported
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A-Cohort 1: GSK3335065 0.1 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A-Cohort 2: GSK3335065 0.25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A-Cohort 3: GSK3335065 1.3 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A-Cohort 4: GSK335065 2.6 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A-Cohort 5: GSK335065 5.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A-Cohort 6: GSK335065 12 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A-Cohort 7: GSK335065 35 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A-Cohort 8: GSK335065 54 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B-Cohort 9: 0.14mg IV Bolus+0.012 mg/Hour IV Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part C: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part C-Cohort 13: GSK3335065
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part C-Cohort 14: GSK3335065
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Placebo
n=5 participants at risk
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 participants at risk
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 participants at risk
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 participants at risk
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
Part B: Placebo
Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
|
Part B-Cohort 9: 0.14mg IV Bolus+0.012 mg/Hour IV Infusion
Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 0.012 mg/ hour for 7 days.
|
Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
|
Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
|
Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
|
Part C: Placebo
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
|
Part C-Cohort 13: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
|
Part C-Cohort 14: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
100.0%
1/1 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
Other adverse events
| Measure |
Part A: Placebo
n=5 participants at risk
Healthy male participants were administered a single intravenous (IV) bolus dose of GSK3335065 matching placebo on Day 1.
|
Part A-Cohort 1: GSK3335065 0.1 mg
n=6 participants at risk
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.1 milligram (mg) on Day 1.
|
Part A-Cohort 2: GSK3335065 0.25 mg
n=6 participants at risk
Healthy male participants were administered a single IV bolus dose of GSK3335065 0.25 mg on Day 1.
|
Part A-Cohort 3: GSK3335065 1.3 mg
n=1 participants at risk
Healthy male participants were administered a single IV bolus dose of GSK3335065 1.3 mg on Day 1.
|
Part A-Cohort 4: GSK335065 2.6 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 2.6 mg.
|
Part A-Cohort 5: GSK335065 5.5 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 5.5 mg.
|
Part A-Cohort 6: GSK335065 12 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 12 mg.
|
Part A-Cohort 7: GSK335065 35 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 35 mg.
|
Part A-Cohort 8: GSK335065 54 mg
Healthy male participants were planned to be administered a single IV bolus dose of GSK335065 54 mg.
|
Part B: Placebo
Healthy male participants were planned to be administered IV bolus dose of placebo on Day 1 followed by continuous IV infusion of placebo for 7 days.
|
Part B-Cohort 9: 0.14mg IV Bolus+0.012 mg/Hour IV Infusion
Participants were planned to be administered an IV bolus dose of GSK3335065 0.14 mg on Day 1 followed by continuous IV infusion of GSK3335065 0.012 mg/ hour for 7 days.
|
Part B-Cohort 10: 7.5 mg IV Bolus+0.63 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 7.5 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 0.63 mg/hour for 7 days.
|
Part B-Cohort 11: 12 mg IV Bolus+1.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 12 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 1.1 mg/hour for 7 days.
|
Part B-Cohort 12: 23 mg IV Bolus Dose+2.1 mg/Hour IV Infusion
Participants were planned to be administered IV bolus dose of GSK3335065 23 mg on Day 1 followed by continuous IV infusion of GSK3335065 at a dose of 2.1 mg/hour for 7 days.
|
Part C: Placebo
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered either a single intravenous dose of placebo or repeat doses of placebo as continuous infusion over 7 days.
|
Part C-Cohort 13: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered a single intravenous dose of GSK3335065.
|
Part C-Cohort 14: GSK3335065
Part C was planned to be conducted in women of non-child bearing potential. Participants were planned to be administered repeat doses of GSK3335065 as continuous IV infusion over 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 2 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
General disorders
Infusion site erythema
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
16.7%
1/6 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
100.0%
1/1 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
100.0%
1/1 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
0.00%
0/6 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
100.0%
1/1 • Number of events 1 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
—
0/0 • Adverse events (AEs) and serious adverse events (SAEs) were collected from admission until follow-up (Up to Day 22) for Part A (Cohorts 1 to 3).
AEs and SAEs were not collected for Part A (Cohorts 4 to 8) and Parts B and C as no participants were enrolled due to termination of the study during Part A-Cohort 3. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place