Trial Outcomes & Findings for Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study (NCT NCT03984812)

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death and is life-threatening which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly, or any other situation that require medical or scientific judgement. Number of participants with common more than or equal to (\>=)5 percent (%) non-serious AEs and SAEs are presented.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Up to Day 28

Results posted on

2021-10-25

Participant Flow

This was to have been a 2 part study, conducted to investigate single ascending doses (SAD) in Part 1 and repeated once-weekly multiple ascending doses (MAD) in Part 2. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.

A total of 24 healthy participants were enrolled in the study across the United States. This study was terminated due to non-safety reasons; hence, Part 1 (Cohorts 4 to 6) and Part 2 were not conducted.

Participant milestones

Participant milestones
Measure	Part 1- Cohort 1: GSK3732394 10 mg Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.	Part 1- Cohort 2: GSK3732394 20 mg Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.	Part 1- Cohort 3: GSK3732394 80 mg Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.	Part 1- Placebo Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.
Part 1 (Up to Day 28) STARTED	6	6	6	6
Part 1 (Up to Day 28) COMPLETED	6	6	5	6
Part 1 (Up to Day 28) NOT COMPLETED	0	0	1	0
Part 2 (Up to Day 49) STARTED	0	0	0	0
Part 2 (Up to Day 49) COMPLETED	0	0	0	0
Part 2 (Up to Day 49) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1- Cohort 1: GSK3732394 10 mg Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.	Part 1- Cohort 2: GSK3732394 20 mg Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.	Part 1- Cohort 3: GSK3732394 80 mg Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.	Part 1- Placebo Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.	Part 1- Cohort 4: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394	Part 1- Cohort 5: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.	Part 1- Cohort 6: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.	Part 2- Cohort 1: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.	Part 2- Cohort 2: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22	Part 2- Cohort 3: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.	Part 2: Placebo Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 matching placebo on Days 1, 8, 15 and 22 in cohorts 1, 2 and 3.
Part 1 (Up to Day 28) Withdrawal by Subject	0	0	1	0	0	0	0	0	0	0	0

Baseline Characteristics

Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1- Cohort 1: GSK3732394 10 mg n=6 Participants Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.	Part 1- Cohort 2: GSK3732394 20 mg n=6 Participants Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.	Part 1- Cohort 3: GSK3732394 80 mg n=6 Participants Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.	Part 1- Placebo n=6 Participants Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.	Part 1- Cohort 4: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394	Part 1- Cohort 5: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.	Part 1- Cohort 6: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.	Part 2- Cohort 1: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.	Part 2- Cohort 2: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22	Part 2- Cohort 3: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.	Part 2: Placebo Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 matching placebo on Days 1, 8, 15 and 22 in cohorts 1, 2 and 3.	Total n=24 Participants Total of all reporting groups
Age, Continuous	41.7 Years STANDARD_DEVIATION 5.82 • n=5 Participants	34.3 Years STANDARD_DEVIATION 10.80 • n=7 Participants	38.7 Years STANDARD_DEVIATION 6.95 • n=5 Participants	33.0 Years STANDARD_DEVIATION 11.44 • n=4 Participants	—	—	—	—	—	—	—	36.9 Years STANDARD_DEVIATION 9.17 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	14 Participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Asian- Japanese Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian- South East Asian Heritage	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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White- White/Caucasian/European Heritage	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native and African American/African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native and White/Caucasian/European Heritage	0 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to Day 28

Population: Safety Population consisted of all participants who received at least 1 dose of study treatment. Participants will be analyzed according to the treatment they actually received. Data was not collected for Cohort 4 to 6, as the study was terminated after Part 1-Cohort 3 and hence no participants were enrolled. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death and is life-threatening which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly, or any other situation that require medical or scientific judgement. Number of participants with common more than or equal to (\>=)5 percent (%) non-serious AEs and SAEs are presented.

Outcome measures

Outcome measures
Measure	Part 1- Cohort 1: GSK3732394 10 mg n=6 Participants Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.	Part 1- Cohort 2: GSK3732394 20 mg n=6 Participants Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.	Part 1- Cohort 3: GSK3732394 80 mg n=6 Participants Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.	Part 1- Placebo n=6 Participants Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.	Part 1- Cohort 4: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394	Part 1- Cohort 5: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.	Part 1- Cohort 6: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.
Part 1: Number of Participants With Non-serious Adverse Event (SAEs) and SAEs Non-SAEs	4 Participants	4 Participants	4 Participants	2 Participants	—	—	—
Part 1: Number of Participants With Non-serious Adverse Event (SAEs) and SAEs SAEs	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

Other adverse events

Other adverse events
Measure	Part 1- Cohort 1: GSK3732394 10 mg n=6 participants at risk Healthy adult participants were administered a single subcutaneous (SC) dose of blinded GSK3732394 10 milligrams (mg) on Day 1.	Part 1- Cohort 2: GSK3732394 20 mg n=6 participants at risk Healthy adult participants were administered a single SC dose of blinded GSK3732394 20 mg on Day 1.	Part 1- Cohort 3: GSK3732394 80 mg n=6 participants at risk Healthy adult participants were administered a single SC dose of blinded GSK3732394 80 mg on Day 1.	Part 1- Placebo n=6 participants at risk Healthy adult participants were administered a single SC dose of blinded GSK3732394 matching placebo on Day 1 in cohorts 1, 2, and 3.	Part 1- Cohort 4: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394	Part 1- Cohort 5: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.	Part 1- Cohort 6: GSK3732394 Healthy adult participants were planned to be administered a single SC dose of blinded GSK3732394.	Part 2- Cohort 1: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.	Part 2- Cohort 2: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22	Part 2- Cohort 3: GSK3732394 Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 on Days 1, 8, 15 and 22.	Part 2: Placebo Healthy adult participants were planned to be administered a weekly dose of SC GSK3732394 matching placebo on Days 1, 8, 15 and 22 in cohorts 1, 2 and 3.
General disorders Injection site hypersensitivity	50.0% 3/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	33.3% 2/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	50.0% 3/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
General disorders Chest pain	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
General disorders Injection site bruising	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
General disorders Vessel puncture site pain	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
General disorders Vessel puncture site swelling	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Infections and infestations Folliculitis	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Investigations Transaminases increased	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Nervous system disorders Headache	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	0.00% 0/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	16.7% 1/6 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.	— 0/0 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 28. Safety Population consisted of all participants who received at least 1 dose of study treatment. Data is presented for Part 1- Cohorts 1 to 3. Non-SAEs and SAEs were not collected for Part 1 (Cohorts 4 to 6) and Part 2 as the study was terminated after Part 1-Cohort 3.

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

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