Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of GSK3923868 Inhalation Powder in Healthy Participants and Stable Asthmatics (NCT NCT04585009)
NCT ID: NCT04585009
Last Updated: 2024-02-20
Results Overview
AEs and SAEs were collected. 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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-1 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Up to Day 43
Results posted on
2024-02-20
Participant Flow
This was a three-part study with single dose escalation in Part A and repeat dose in Part B and C. Part A and B was conducted in healthy volunteers and Part C was conducted in participants with asthma.
A total of 56 participants (28 in Part A ,17 in Part B and 11 in Part C) were enrolled in this study. This study was conducted at a single center in the United Kingdom.
Participant milestones
| Measure |
Cohort 1: GSK3923868 50 Micrograms (mcg)/ Placebo/ 250mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/Placebo/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: GSK3923868 50 mcg/ 100 mcg/ Placebo
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/Placebo in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: GSK3923868 50mcg/ 100mcg/ 250mcg
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: Placebo / GSK3923868 100 mcg/ 250 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day1 in the planned treatment sequence: Placebo/GSK3923868 100 mcg/GSK3923868 250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 2: Placebo / GSK3923868 1000 mcg/ 3000 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: Placebo/GSK3923868 1000 mcg/GSK3923868 3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500 mcg/ Placebo/ 3000 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/Placebo/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500 mcg/ 1000 mcg/ Placebo
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/Placebo in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500mcg/ 1000mcg/ 3000mcg
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 3 and 4: Placebo
Healthy participants received placebo matched to GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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PartA, Cohort1, Treatment Period1(Day1)
STARTED
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3
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3
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3
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3
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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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PartA, Cohort1, Treatment Period1(Day1)
COMPLETED
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2
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3
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3
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3
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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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PartA, Cohort1, Treatment Period1(Day1)
NOT COMPLETED
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1
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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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Cohort1: Washout Period1 (10Days)
STARTED
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2
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3
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3
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3
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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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Cohort1: Washout Period1 (10Days)
COMPLETED
|
2
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3
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3
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3
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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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Cohort1: Washout Period1 (10Days)
NOT COMPLETED
|
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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PartA, Cohort1,Treatment Period2(Day1)
STARTED
|
3
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3
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3
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3
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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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PartA, Cohort1,Treatment Period2(Day1)
COMPLETED
|
2
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3
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3
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3
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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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PartA, Cohort1,Treatment Period2(Day1)
NOT COMPLETED
|
1
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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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Cohort1: Washout Period2(10 Days)
STARTED
|
2
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3
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3
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3
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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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Cohort1: Washout Period2(10 Days)
COMPLETED
|
2
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3
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3
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3
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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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Cohort1: Washout Period2(10 Days)
NOT COMPLETED
|
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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PartA, Cohort1, Treatment Period3(Day1)
STARTED
|
3
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3
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3
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3
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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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PartA, Cohort1, Treatment Period3(Day1)
COMPLETED
|
3
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3
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3
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3
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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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PartA, Cohort1, Treatment Period3(Day1)
NOT COMPLETED
|
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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PartA, Cohort2: Treatment Period4(Day1)
STARTED
|
0
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0
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0
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0
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3
|
3
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3
|
3
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0
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0
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0
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0
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PartA, Cohort2: Treatment Period4(Day1)
COMPLETED
|
0
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0
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0
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0
|
3
|
3
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3
|
2
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0
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0
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0
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0
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PartA, Cohort2: Treatment Period4(Day1)
NOT COMPLETED
|
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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1
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0
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0
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0
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0
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Cohort2: Washout Period1 (10 Days)
STARTED
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0
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0
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0
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0
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3
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3
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3
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2
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0
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0
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0
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0
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Cohort2: Washout Period1 (10 Days)
COMPLETED
|
0
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0
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0
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0
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3
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3
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3
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2
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0
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0
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0
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0
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Cohort2: Washout Period1 (10 Days)
NOT COMPLETED
|
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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PartA, Cohort2: Treatment Period5(Day1)
STARTED
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0
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0
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0
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0
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3
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3
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3
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3
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0
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0
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0
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0
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PartA, Cohort2: Treatment Period5(Day1)
COMPLETED
|
0
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0
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0
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0
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2
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3
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3
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3
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0
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0
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0
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0
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PartA, Cohort2: Treatment Period5(Day1)
NOT COMPLETED
|
0
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0
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0
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0
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1
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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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Cohort2: Washout Period2 (10 Days)
STARTED
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0
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0
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0
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0
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2
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3
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3
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3
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0
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0
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0
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0
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Cohort2: Washout Period2 (10 Days)
COMPLETED
|
0
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0
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0
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0
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2
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3
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3
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3
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0
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0
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0
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0
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Cohort2: Washout Period2 (10 Days)
NOT COMPLETED
|
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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PartA, Cohort2: Treatment Period6(Day1)
STARTED
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0
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0
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0
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0
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3
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3
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3
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3
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0
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0
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0
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0
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PartA, Cohort2: Treatment Period6(Day1)
COMPLETED
|
0
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0
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0
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0
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3
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3
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3
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3
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0
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0
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0
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0
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PartA, Cohort2: Treatment Period6(Day1)
NOT COMPLETED
|
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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Part B, Cohorts 3 & 4 (Days 1 to 14)
STARTED
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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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4
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13
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0
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0
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Part B, Cohorts 3 & 4 (Days 1 to 14)
COMPLETED
|
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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4
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12
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0
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0
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Part B, Cohorts 3 & 4 (Days 1 to 14)
NOT COMPLETED
|
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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1
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0
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0
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Part C, Cohort 5 (Days 1 to 7)
STARTED
|
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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3
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8
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Part C, Cohort 5 (Days 1 to 7)
COMPLETED
|
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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3
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7
|
|
Part C, Cohort 5 (Days 1 to 7)
NOT COMPLETED
|
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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1
|
Reasons for withdrawal
| Measure |
Cohort 1: GSK3923868 50 Micrograms (mcg)/ Placebo/ 250mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/Placebo/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: GSK3923868 50 mcg/ 100 mcg/ Placebo
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/Placebo in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: GSK3923868 50mcg/ 100mcg/ 250mcg
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: Placebo / GSK3923868 100 mcg/ 250 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day1 in the planned treatment sequence: Placebo/GSK3923868 100 mcg/GSK3923868 250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 2: Placebo / GSK3923868 1000 mcg/ 3000 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: Placebo/GSK3923868 1000 mcg/GSK3923868 3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500 mcg/ Placebo/ 3000 mcg
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/Placebo/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500 mcg/ 1000 mcg/ Placebo
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/Placebo in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500mcg/ 1000mcg/ 3000mcg
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 3 and 4: Placebo
Healthy participants received placebo matched to GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 3 and 4: GSK3923868 3000mcg
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 5: Placebo
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 5: GSK3923868 3000mcg
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PartA, Cohort1, Treatment Period1(Day1)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartA, Cohort1,Treatment Period2(Day1)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PartA, Cohort2: Treatment Period4(Day1)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
PartA, Cohort2: Treatment Period5(Day1)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B, Cohorts 3 & 4 (Days 1 to 14)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part C, Cohort 5 (Days 1 to 7)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of GSK3923868 Inhalation Powder in Healthy Participants and Stable Asthmatics
Baseline characteristics by cohort
| Measure |
Cohort 1: GSK3923868 50 Micrograms (mcg)/ Placebo/ 250mcg
n=5 Participants
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/Placebo/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: GSK3923868 50 mcg/ 100 mcg/ Placebo
n=3 Participants
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/Placebo in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: GSK3923868 50mcg/ 100mcg/ 250mcg
n=3 Participants
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 50 mcg/100 mcg/250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 1: Placebo / GSK3923868 100 mcg/ 250 mcg
n=3 Participants
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day1 in the planned treatment sequence: Placebo/GSK3923868 100 mcg/GSK3923868 250 mcg in treatment periods 1, 2 and 3 respectively. There was a washout of at least 10 days after Treatment Periods 1 and 2. Participants were followed up for 7 to 14 days after last dose in Treatment Period 3.
|
Cohort 2: Placebo / GSK3923868 1000 mcg/ 3000 mcg
n=4 Participants
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: Placebo/GSK3923868 1000 mcg/GSK3923868 3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500 mcg/ Placebo/ 3000 mcg
n=3 Participants
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/Placebo/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500 mcg/ 1000 mcg/ Placebo
n=3 Participants
Healthy participants received single ascending doses of GSK3923868, or placebo matched to GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/Placebo in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 2: GSK3923868 500mcg/ 1000mcg/ 3000mcg
n=4 Participants
Healthy participants received single ascending doses of GSK3923868 on Day 1 in the planned treatment sequence: GSK3923868 500 mcg/1000 mcg/3000 mcg in treatment periods 4, 5 and 6 respectively. There was a washout of at least 10 days after Treatment Periods 4 and 5. Participants were followed up for 7 to 14 days after last dose in Treatment Period 6.
|
Cohort 3 and 4: Placebo
n=4 Participants
Healthy participants received placebo matched to GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 3 and 4: GSK3923868 3000mcg
n=13 Participants
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 5: Placebo
n=3 Participants
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 5: GSK3923868 3000mcg
n=8 Participants
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Age, Customized
19-64
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
56 Participants
n=36 Participants
|
|
Age, Customized
>=65
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
56 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
44 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
MIXED RACE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to Day 43Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
AEs and SAEs were collected. 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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-1 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort-1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Part A, Cohort-1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 43Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
AEs and SAEs were collected. 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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part A, Cohort-2 from the start of dosing and post-dose washout period (10 days) after treatment periods was reported.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort 2: Number of Participants With AEs and SAEs
AEs
|
5 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Part A, Cohort 2: Number of Participants With AEs and SAEs
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
AEs and SAEs were collected. 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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part B, Cohort-3 and 4 (repeat dose) of the study were reported. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=13 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=4 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part B: Number of Participants With AEs and SAEs
AEs
|
12 Participants
|
—
|
4 Participants
|
—
|
—
|
—
|
|
Part B: Number of Participants With AEs and SAEs
SAEs
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 21Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
AEs and SAEs were collected. 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. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Number of participants with AEs and SAEs assessed in Part C, Cohort-5 (repeat dose) of the study were reported.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=8 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=3 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part C: Number of Participants With AEs and SAEs
AEs
|
8 Participants
|
—
|
3 Participants
|
—
|
—
|
—
|
|
Part C: Number of Participants With AEs and SAEs
SAEs
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 2 in each treatment periodPopulation: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Laboratory Parameters
Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Laboratory Parameters
Clinical Chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 2 in each treatment periodPopulation: The analysis was performed on the Safety Set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Clinical Chemistry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Hematology
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 18Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4). Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=13 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=4 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Clinical Chemistry
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Hematology
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 8Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
The laboratory (lab) measurements included Clinical chemistry and hematology. The parameters evaluated were hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium Corrected for Albumin, Creatinine, Glucose, Potassium and Sodium. Number of participants with clinically significant changes from baseline in clinical chemistry and hematology were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=8 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=3 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Clinical Chemistry
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part C: Number of Participants With Clinically Significant Changes in Clinical Chemistry and Hematology Lab Parameters
Hematology
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 2 in each treatment periodPopulation: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in parameters for cohort-1 were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
12-Lead ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 2 in each treatment periodPopulation: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in parameters for cohort-2 were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
12-Lead ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 18Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4). Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=13 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=4 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital Signs
|
6 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
12-Lead ECG
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 8Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in parameters for cohort-5 were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=8 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=3 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
Vital Signs
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Part C: Number of Participants With Clinically Significant Changes in Vital Signs and 12-Lead ECG Findings
12-Lead ECG
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 2 in each treatment periodPopulation: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort-1: Number of Participants With Clinically Significant Changes in Spirometry Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 2 in each treatment periodPopulation: The analysis was performed on the Safety Set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort-2: Number of Participants With Clinically Significant Changes in Spirometry Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) up to Day 18Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=13 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=4 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Spirometry Measurements
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of the treatment (Day 1) to Day 8Population: The analysis was performed on the safety set that includes all randomized participants who received at least 1 dose of study intervention. Participants were analyzed according to the treatment they received.
Spirometry included forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) for lung function assessment. Number of participants with clinically significant changes in parameters were reported. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=8 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=3 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Clinically Significant Changes in Spirometry Measurements
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 2 in each treatment periodPopulation: The analysis was performed on the Pharmacokinetic (PK) Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values were to be considered as non-missing values). Participants were analyzed according to the treatment they received.
Blood samples were collected for measurement of plasma concentrations of GSK3923868. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration values were reported. Single ascending doses of GSK3923868 were assessed in 2 sequential crossover cohorts (Cohorts 1 and 2) of healthy participants, each with up to 3 treatment periods.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort 1 and 2: Area Under the Plasma GSK3923868 Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-t])
|
3810.3 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 39.08
|
8111.1 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 33.37
|
1774.65 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 48.78
|
22550.14 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 24.76
|
49756.36 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 22.85
|
144519.79 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 24.37
|
SECONDARY outcome
Timeframe: Up to Day 2 in each treatment periodPopulation: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received.
Blood samples were collected for measurement of plasma concentrations of GSK3923868. Area under the concentration-time curve from time zero extrapolated to infinite time values were reported.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort 1 and 2: Area Under the Plasma GSK3923868 Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf])
|
4125.22 h*pg/mL
Geometric Coefficient of Variation 40.59
|
8656.56 h*pg/mL
Geometric Coefficient of Variation 34.71
|
1964.21 h*pg/mL
Geometric Coefficient of Variation 50.59
|
22941.62 h*pg/mL
Geometric Coefficient of Variation 24.69
|
50504.33 h*pg/mL
Geometric Coefficient of Variation 22.89
|
146453.53 h*pg/mL
Geometric Coefficient of Variation 24.53
|
SECONDARY outcome
Timeframe: Up to Day 2 in each treatment periodPopulation: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received.
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort 1 and 2: Maximum Observed GSK3923868 Plasma Concentration (Cmax)
|
772.49 Picograms Per Milliliter (pg/mL)
Geometric Coefficient of Variation 29.19
|
1811.8 Picograms Per Milliliter (pg/mL)
Geometric Coefficient of Variation 27.96
|
370.84 Picograms Per Milliliter (pg/mL)
Geometric Coefficient of Variation 37.29
|
4284.89 Picograms Per Milliliter (pg/mL)
Geometric Coefficient of Variation 23.49
|
9583.02 Picograms Per Milliliter (pg/mL)
Geometric Coefficient of Variation 25.61
|
30985.12 Picograms Per Milliliter (pg/mL)
Geometric Coefficient of Variation 26.09
|
SECONDARY outcome
Timeframe: Up to Day 2 in each treatment periodPopulation: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received.
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=9 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
n=9 Participants
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part A, Cohort 1 and 2: Time to Maximum Observed Plasma Drug Concentration (Tmax)
|
1 Hour (h)
Interval 1.0 to 2.0
|
1 Hour (h)
Interval 0.8 to 1.0
|
1 Hour (h)
Interval 1.0 to 2.0
|
1 Hour (h)
Interval 0.5 to 1.0
|
1 Hour (h)
Interval 0.8 to 2.0
|
0.75 Hour (h)
Interval 0.75 to 1.0
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 4 and did not contribute to the analysis.
Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Area under the concentration-time curve from time zero (predose) to time tau (dosing interval) was reported. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=13 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part B, Cohort 3 and 4: AUC From Time Zero (Predose) to Time Tau (AUC [0-tau]) (Tau=24hours for Once a Day Dosing Regimen) of GSK3923868
Day 1
|
—
|
—
|
128045.03 h*pg/mL
Geometric Coefficient of Variation 31.39
|
—
|
—
|
—
|
|
Part B, Cohort 3 and 4: AUC From Time Zero (Predose) to Time Tau (AUC [0-tau]) (Tau=24hours for Once a Day Dosing Regimen) of GSK3923868
Day 14 (n=12)
|
—
|
—
|
144211.68 h*pg/mL
Geometric Coefficient of Variation 29.45
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 4 and did not contribute to the analysis.
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=13 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part B, Cohort 3 and 4: Cmax of GSK3923868
Day 1
|
—
|
—
|
32342.47 pg/mL
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
|
Part B, Cohort 3 and 4: Cmax of GSK3923868
Day 14 (n=12)
|
—
|
—
|
31270.98 pg/mL
Geometric Coefficient of Variation 26.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 14Population: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 4 and did not contribute to the analysis.
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis. Part B assessed repeat doses of study drug across two parallel cohorts (Cohorts 3 and 4).
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=13 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part B, Cohort 3 and 4: Tmax of GSK3923868
Day 1
|
—
|
—
|
0.75 Hour (h)
Interval 0.75 to 1.0
|
—
|
—
|
—
|
|
Part B, Cohort 3 and 4: Tmax of GSK3923868
Day 14 (n=12)
|
—
|
—
|
1 Hour (h)
Interval 0.5 to 1.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 7Population: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 7 and did not contribute to the analysis.
Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=8 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part C: AUC (0-tau) (Tau=24 Hours for Once a Day Dosing Regimen) of GSK3923868
Day 7 (n=7)
|
—
|
—
|
136461.8 h*pg/mL
Geometric Coefficient of Variation 24.21
|
—
|
—
|
—
|
|
Part C: AUC (0-tau) (Tau=24 Hours for Once a Day Dosing Regimen) of GSK3923868
Day 1
|
—
|
—
|
97412.11 h*pg/mL
Geometric Coefficient of Variation 39.87
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 7Population: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 7 and did not contribute to the analysis.
Cmax was defined as the maximum concentration of drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=8 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part C: Cmax of GSK3923868
Day 1
|
—
|
—
|
27799.34 pg/mL
Geometric Coefficient of Variation 25.2
|
—
|
—
|
—
|
|
Part C: Cmax of GSK3923868
Day 7 (n=7)
|
—
|
—
|
35484.07 pg/mL
Geometric Coefficient of Variation 11.97
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 7Population: The analysis was performed on the PK Set that includes all randomized participants who received at least 1 dose of study intervention and had at least 1 non-missing PK assessment (NQ values were to be considered as non-missing values). Participants were analyzed according to the treatment they received. One participant was withdrawn before dosing on Day 7 and did not contribute to the analysis.
Tmax was defined as time required to achieve Cmax for drug GSK3923868 in plasma. Blood samples were collected for measurement of plasma concentrations of GSK3923868 for PK analysis.
Outcome measures
| Measure |
Cohort 2: GSK3923868 500 mcg
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: Placebo
n=8 Participants
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
Cohort 2: GSK3923868 3000mcg
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods.
|
|---|---|---|---|---|---|---|
|
Part C: Tmax of GSK3923868
Day 1
|
—
|
—
|
0.758 Hour (h)
Interval 0.5 to 1.0
|
—
|
—
|
—
|
|
Part C: Tmax of GSK3923868
Day 7 (n=7)
|
—
|
—
|
0.75 Hour (h)
Interval 0.75 to 1.0
|
—
|
—
|
—
|
Adverse Events
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: GSK3923868 50 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: GSK3923868 100 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: GSK3923868 250mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: GSK3923868 500 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: GSK3923868 1000 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: GSK3923868 3000mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 and 4: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3 and 4: GSK3923868 3000mcg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 5: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5: GSK3923868 3000mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Placebo
n=9 participants at risk
Healthy participants received a single dose (SD) of placebo in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 50 mcg
n=9 participants at risk
Healthy participants received a SD of GSK3923868 50 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 100 mcg
n=9 participants at risk
Healthy participants received a SD of GSK3923868 100 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 1: GSK3923868 250mcg
n=9 participants at risk
Healthy participants received a SD of GSK3923868 250 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: Placebo
n=9 participants at risk
Healthy participants received a single dose (SD) of placebo matched to GSK3923868 in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 500 mcg
n=9 participants at risk
Healthy participants received a SD of GSK3923868 500 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 1000 mcg
n=9 participants at risk
Healthy participants received a SD of GSK3923868 1000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 2: GSK3923868 3000mcg
n=9 participants at risk
Healthy participants received a SD of GSK3923868 3000 mcg in one of the 3 treatment periods. A washout period of at least 10 days was maintained between treatment periods. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 3 and 4: Placebo
n=4 participants at risk
Healthy participants received placebo daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 3 and 4: GSK3923868 3000mcg
n=13 participants at risk
Healthy participants received planned repeat doses of 3000 mcg GSK3923868 daily for 14 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 5: Placebo
n=3 participants at risk
Participants with stable asthma received placebo matched to GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
Cohort 5: GSK3923868 3000mcg
n=8 participants at risk
Participants with stable asthma received a planned repeat dosing of 3000 mcg GSK3923868 daily for 7 days. Participants were followed up for 7 to 14 days post last dose of the study treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Chills
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
50.0%
2/4 • Number of events 2 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
38.5%
5/13 • Number of events 5 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Feeling hot
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
30.8%
4/13 • Number of events 4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Medical device site dermatitis
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Pain
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Aspartate aminotransferase inc
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood creatine phosphokinase i
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Body temperature increased
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Number of events 2 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
3/9 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
3/9 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
3/9 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Number of events 2 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
3/9 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Number of events 2 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
38.5%
5/13 • Number of events 5 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
87.5%
7/8 • Number of events 7 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Number of events 2 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
75.0%
3/4 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
53.8%
7/13 • Number of events 7 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
37.5%
3/8 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
22.2%
2/9 • Number of events 2 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
30.8%
4/13 • Number of events 4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Product Issues
Product after taste
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Product Issues
Product taste abnormal
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
23.1%
3/13 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/8 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
3/9 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/9 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
11.1%
1/9 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/4 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
12.5%
1/8 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected for Part A: Up to Day 43; for Part B: Up to Day 28 and for Part C: Up to Day 21.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER