Trial Outcomes & Findings for First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK3389404 in Healthy Subjects (NCT NCT02647281)

Results Overview

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AELD were considered for analysis. Safety Population comprised of all participants who received at least 1 dose of study treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

56 participants

Primary outcome timeframe

Up to 62 days

Results posted on

2019-07-16

Participant Flow

This was a Phase 1, randomized, double-blind (sponsor un-blinded), placebo-controlled, dose escalation study to determine the safety, tolerability, and pharmacokinetic (PK) profile of GSK3389404 as single and multiple subcutaneous (SC) injections in healthy participants. This study was conducted at 2 centers in London, United Kingdom.

The study was conducted in 2 Parts: Single-Ascending Dose (Part 1) and Multiple-Ascending Dose (Part 2). In Part 1, total of 32 participants were enrolled and all of them were randomized to receive the study treatment. In Part 2, a total of 24 participants were enrolled and all of them were randomized to receive the study treatment.

Participant milestones

Participant milestones
Measure	Part 1: Placebo Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.	Part 2: Placebo Participant received a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2.	Part 2: GSK3389404 30 mg Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.	Part 2: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.	Part 2: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
Single-Ascending Dose(Part 1-62 Days) STARTED	8	6	6	6	6	0	0	0	0
Single-Ascending Dose(Part 1-62 Days) COMPLETED	8	6	6	6	6	0	0	0	0
Single-Ascending Dose(Part 1-62 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0
Multiple-Ascending Dose(Part 2-115 Days) STARTED	0	0	0	0	0	6	6	6	6
Multiple-Ascending Dose(Part 2-115 Days) COMPLETED	0	0	0	0	0	6	6	6	5
Multiple-Ascending Dose(Part 2-115 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Placebo Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.	Part 2: Placebo Participant received a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2.	Part 2: GSK3389404 30 mg Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.	Part 2: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.	Part 2: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
Multiple-Ascending Dose(Part 2-115 Days) Withdrawal by Subject	0	0	0	0	0	0	0	0	1

Baseline Characteristics

N=32 for Part 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.	Part 2: Placebo n=6 Participants Participant received a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2.	Part 2: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.	Part 2: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.	Part 2: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.	Total n=56 Participants Total of all reporting groups
Age, Continuous	28.1 Years STANDARD_DEVIATION 8.22 • n=8 Participants • N=32 for Part 1	27.5 Years STANDARD_DEVIATION 3.78 • n=6 Participants • N=32 for Part 1	37.5 Years STANDARD_DEVIATION 12.44 • n=6 Participants • N=32 for Part 1	32.8 Years STANDARD_DEVIATION 7.41 • n=6 Participants • N=32 for Part 1	37.8 Years STANDARD_DEVIATION 13.41 • n=6 Participants • N=32 for Part 1	38.0 Years STANDARD_DEVIATION 11.78 • n=6 Participants • N=24 for Part 2	32.2 Years STANDARD_DEVIATION 6.91 • n=6 Participants • N=24 for Part 2	40.5 Years STANDARD_DEVIATION 11.13 • n=6 Participants • N=24 for Part 2	38.5 Years STANDARD_DEVIATION 12.23 • n=6 Participants • N=24 for Part 2	37.3 Years STANDARD_DEVIATION 10.49 • n=24 Participants • N=24 for Part 2
Sex: Female, Male Female	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=56 Participants
Sex: Female, Male Male	8 Participants n=8 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	54 Participants n=56 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Asian-South East Asian heritage	0 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=56 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · African American/African heritage	0 Participants n=8 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=56 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · White-White/Caucasian/European heritage	8 Participants n=8 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	6 Participants n=6 Participants	45 Participants n=56 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Asian-Central/South Asian heritage	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=56 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Caribbean	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=56 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Caribbean British	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=56 Participants

PRIMARY outcome

Timeframe: Up to 62 days

Population: Safety Population

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AELD were considered for analysis. Safety Population comprised of all participants who received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Number of Participants With Any Non-serious Adverse Event (AE); Any Serious AE (SAE); Any AEs Leading to Discontinuation of Study Treatment (AELD) in Part 1 Any non-serious AE	4 Participants	3 Participants	2 Participants	3 Participants	5 Participants
Number of Participants With Any Non-serious Adverse Event (AE); Any Serious AE (SAE); Any AEs Leading to Discontinuation of Study Treatment (AELD) in Part 1 Any SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Non-serious Adverse Event (AE); Any Serious AE (SAE); Any AEs Leading to Discontinuation of Study Treatment (AELD) in Part 1 AELD	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 115 days

Population: Safety Population

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AELD were considered for analysis.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Number of Participants With Any Non-serious AE; Any SAE; Any AELD in Part 2 Any non-serious AE	3 Participants	5 Participants	2 Participants	4 Participants	—
Number of Participants With Any Non-serious AE; Any SAE; Any AELD in Part 2 Any SAE	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Any Non-serious AE; Any SAE; Any AELD in Part 2 AELD	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Up to 62 days

Population: Safety Population

Blood samples were collected for hematology, clinical chemistry, coagulation parameters and urinalysis. Abnormalities of potential clinical importance were evaluated as per Division of Acquired Immune Deficiency Syndrome \[DAIDS\] table for grading the severity of adult and pediatric adverse events. Laboratory abnormalities of DAIDS Grade 1 or higher were considered as of potential clinical importance and were summarized.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Number of Participants With Laboratory Values of Potential Clinical Importance in Part 1	5 Participants	3 Participants	2 Participants	4 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to 115 days

Population: Safety Population

Blood samples were collected for hematology, clinical chemistry, coagulation parameters and urinalysis. Abnormalities of potential clinical importance were evaluated as per DAIDS table for grading the severity of adult and pediatric adverse events. Laboratory abnormalities of DAIDS Grade 1 or higher were considered as of potential clinical importance and were summarized.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Number of Participants With Laboratory Values of Potential Clinical Importance in Part 2	3 Participants	2 Participants	5 Participants	3 Participants	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 31 days

Population: Safety Population

Blood samples were collected to evaluate complement factors (C3 and C4) levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between minimum level (lowest of the measurements for specimens collected) observed post-dose and pre-study drug administration.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Complement Factor Component 3 (C3) and C4 Levels in Part 1 C3	-0.0811 Gram per liter (g/L) Standard Deviation 0.09367	-0.0142 Gram per liter (g/L) Standard Deviation 0.04549	-0.1580 Gram per liter (g/L) Standard Deviation 0.12739	-0.0900 Gram per liter (g/L) Standard Deviation 0.07452	-0.0412 Gram per liter (g/L) Standard Deviation 0.06432
Change From Baseline in Complement Factor Component 3 (C3) and C4 Levels in Part 1 C4	-0.0320 Gram per liter (g/L) Standard Deviation 0.04107	-0.0123 Gram per liter (g/L) Standard Deviation 0.01768	-0.0600 Gram per liter (g/L) Standard Deviation 0.04544	-0.0212 Gram per liter (g/L) Standard Deviation 0.01987	-0.0250 Gram per liter (g/L) Standard Deviation 0.01979

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 31 days

Population: Safety Population

Blood samples were collected to evaluate complement split product C5a levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (highest of the measurements for specimens collected) observed post-dose and pre-study drug administration.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Complement Split Product C5a Levels in Part 1	7.895 Microgram per liter (ug/L) Standard Deviation 4.6360	7.755 Microgram per liter (ug/L) Standard Deviation 8.8013	2.590 Microgram per liter (ug/L) Standard Deviation 1.9653	5.102 Microgram per liter (ug/L) Standard Deviation 18.7596	1.485 Microgram per liter (ug/L) Standard Deviation 2.5368

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 31 days

Population: Safety Population

Blood samples were collected to evaluate complement split product Bb levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (highest of the measurements for specimens collected) observed post-dose and pre-study drug administration

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Complement Split Product Bb Levels in Part 1	0.8788 mg per liter (mg/L) Standard Deviation 1.01171	1.5517 mg per liter (mg/L) Standard Deviation 1.26063	0.6900 mg per liter (mg/L) Standard Deviation 0.48187	1.2900 mg per liter (mg/L) Standard Deviation 1.69068	0.3350 mg per liter (mg/L) Standard Deviation 0.78899

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and Day 22

Population: Safety Population

Blood samples were collected to evaluate complement factors (C3 and C4) levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between minimum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Complement Factor C3 and C4 Levels in Part 2 C3, Day 1	-0.0495 G/L Standard Deviation 0.06661	-0.0333 G/L Standard Deviation 0.05961	-0.0783 G/L Standard Deviation 0.04025	-0.0293 G/L Standard Deviation 0.05722	—
Change From Baseline in Complement Factor C3 and C4 Levels in Part 2 C3, Day 22	-0.1143 G/L Standard Deviation 0.07139	-0.1013 G/L Standard Deviation 0.06017	-0.0840 G/L Standard Deviation 0.02521	-0.1702 G/L Standard Deviation 0.07908	—
Change From Baseline in Complement Factor C3 and C4 Levels in Part 2 C4, Day 1	-0.0190 G/L Standard Deviation 0.01192	-0.0132 G/L Standard Deviation 0.03511	-0.0470 G/L Standard Deviation 0.02674	-0.0135 G/L Standard Deviation 0.01271	—
Change From Baseline in Complement Factor C3 and C4 Levels in Part 2 C4, Day 22	-0.0397 G/L Standard Deviation 0.02043	-0.0405 G/L Standard Deviation 0.03661	-0.0390 G/L Standard Deviation 0.01980	-0.0443 G/L Standard Deviation 0.02805	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and Day 22

Population: Safety Population

Blood samples were collected to evaluate complement factors C5a levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Complement Factor C5a Levels in Part 2 C5a, Day 1	3.000 ug/L Standard Deviation 4.2895	-1.167 ug/L Standard Deviation 5.8963	2.750 ug/L Standard Deviation 4.1563	11.083 ug/L Standard Deviation 6.3907	—
Change From Baseline in Complement Factor C5a Levels in Part 2 C5a, Day 22	9.083 ug/L Standard Deviation 4.2002	9.667 ug/L Standard Deviation 10.5862	7.333 ug/L Standard Deviation 2.3805	13.667 ug/L Standard Deviation 9.9029	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and Day 22

Population: Safety Population

Blood samples were collected to evaluate complement factors C5a levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Complement Factor Bb Levels in Part 2 Bb, Day 1	0.4217 mg/L Standard Deviation 0.62669	0.5033 mg/L Standard Deviation 0.76727	0.9700 mg/L Standard Deviation 0.60554	1.2667 mg/L Standard Deviation 0.55623	—
Change From Baseline in Complement Factor Bb Levels in Part 2 Bb, Day 22	1.4003 mg/L Standard Deviation 0.56580	1.3447 mg/L Standard Deviation 0.75517	0.6833 mg/L Standard Deviation 0.57597	1.7340 mg/L Standard Deviation 1.05781	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 30 days

Population: Safety Population

SBP and DBP were taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, 1 hour	-4.1 Millimeter of mercury (mmHg) Standard Deviation 6.53	-4.4 Millimeter of mercury (mmHg) Standard Deviation 4.38	-3.8 Millimeter of mercury (mmHg) Standard Deviation 7.36	1.5 Millimeter of mercury (mmHg) Standard Deviation 4.96	2.3 Millimeter of mercury (mmHg) Standard Deviation 4.51
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, 2 hour	-4.1 Millimeter of mercury (mmHg) Standard Deviation 2.46	-3.1 Millimeter of mercury (mmHg) Standard Deviation 4.29	-4.8 Millimeter of mercury (mmHg) Standard Deviation 3.87	0.6 Millimeter of mercury (mmHg) Standard Deviation 3.64	-1.9 Millimeter of mercury (mmHg) Standard Deviation 1.86
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, 4 hour	-1.8 Millimeter of mercury (mmHg) Standard Deviation 3.64	-5.6 Millimeter of mercury (mmHg) Standard Deviation 7.39	-0.6 Millimeter of mercury (mmHg) Standard Deviation 7.39	-0.8 Millimeter of mercury (mmHg) Standard Deviation 5.05	-0.4 Millimeter of mercury (mmHg) Standard Deviation 5.42
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, 8 hour	-5.6 Millimeter of mercury (mmHg) Standard Deviation 3.66	-5.4 Millimeter of mercury (mmHg) Standard Deviation 8.78	-4.0 Millimeter of mercury (mmHg) Standard Deviation 7.93	-0.7 Millimeter of mercury (mmHg) Standard Deviation 4.43	-1.3 Millimeter of mercury (mmHg) Standard Deviation 4.34
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, 12 hour	-3.2 Millimeter of mercury (mmHg) Standard Deviation 7.50	-5.8 Millimeter of mercury (mmHg) Standard Deviation 10.30	-3.8 Millimeter of mercury (mmHg) Standard Deviation 4.01	-1.5 Millimeter of mercury (mmHg) Standard Deviation 4.37	-1.4 Millimeter of mercury (mmHg) Standard Deviation 4.34
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, 24 hour	-2.8 Millimeter of mercury (mmHg) Standard Deviation 4.29	-4.3 Millimeter of mercury (mmHg) Standard Deviation 7.53	0.2 Millimeter of mercury (mmHg) Standard Deviation 9.20	0.1 Millimeter of mercury (mmHg) Standard Deviation 4.00	-2.6 Millimeter of mercury (mmHg) Standard Deviation 4.11
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, 48 hour	-2.7 Millimeter of mercury (mmHg) Standard Deviation 4.59	-3.3 Millimeter of mercury (mmHg) Standard Deviation 6.22	-3.0 Millimeter of mercury (mmHg) Standard Deviation 6.87	-1.3 Millimeter of mercury (mmHg) Standard Deviation 4.78	-1.4 Millimeter of mercury (mmHg) Standard Deviation 2.50
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, 72 hour	-1.9 Millimeter of mercury (mmHg) Standard Deviation 4.38	-2.2 Millimeter of mercury (mmHg) Standard Deviation 5.71	1.0 Millimeter of mercury (mmHg) Standard Deviation 7.08	0.5 Millimeter of mercury (mmHg) Standard Deviation 1.25	-2.7 Millimeter of mercury (mmHg) Standard Deviation 3.19
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, Day 8	-3.1 Millimeter of mercury (mmHg) Standard Deviation 5.07	-3.4 Millimeter of mercury (mmHg) Standard Deviation 4.60	-4.6 Millimeter of mercury (mmHg) Standard Deviation 4.53	0.3 Millimeter of mercury (mmHg) Standard Deviation 7.33	-2.0 Millimeter of mercury (mmHg) Standard Deviation 2.91
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 DBP, Day 30	-1.7 Millimeter of mercury (mmHg) Standard Deviation 6.28	0.5 Millimeter of mercury (mmHg) Standard Deviation 7.36	-5.1 Millimeter of mercury (mmHg) Standard Deviation 6.92	2.1 Millimeter of mercury (mmHg) Standard Deviation 7.26	-0.3 Millimeter of mercury (mmHg) Standard Deviation 4.32
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, 1 hour	-2.0 Millimeter of mercury (mmHg) Standard Deviation 7.65	-4.0 Millimeter of mercury (mmHg) Standard Deviation 3.85	-0.8 Millimeter of mercury (mmHg) Standard Deviation 8.55	1.8 Millimeter of mercury (mmHg) Standard Deviation 6.22	0.2 Millimeter of mercury (mmHg) Standard Deviation 6.18
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, 2 hour	-0.7 Millimeter of mercury (mmHg) Standard Deviation 5.63	0.3 Millimeter of mercury (mmHg) Standard Deviation 5.89	2.2 Millimeter of mercury (mmHg) Standard Deviation 8.08	2.1 Millimeter of mercury (mmHg) Standard Deviation 5.51	4.9 Millimeter of mercury (mmHg) Standard Deviation 3.67
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, 4 hour	-1.5 Millimeter of mercury (mmHg) Standard Deviation 4.58	-5.5 Millimeter of mercury (mmHg) Standard Deviation 6.42	-0.9 Millimeter of mercury (mmHg) Standard Deviation 4.32	-4.6 Millimeter of mercury (mmHg) Standard Deviation 7.68	0.3 Millimeter of mercury (mmHg) Standard Deviation 5.94
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, 8 hour	-1.6 Millimeter of mercury (mmHg) Standard Deviation 6.27	-4.6 Millimeter of mercury (mmHg) Standard Deviation 11.61	-2.3 Millimeter of mercury (mmHg) Standard Deviation 5.31	1.2 Millimeter of mercury (mmHg) Standard Deviation 5.61	4.1 Millimeter of mercury (mmHg) Standard Deviation 4.19
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, 12 hour	1.6 Millimeter of mercury (mmHg) Standard Deviation 10.73	-5.5 Millimeter of mercury (mmHg) Standard Deviation 10.15	0.8 Millimeter of mercury (mmHg) Standard Deviation 4.58	-1.5 Millimeter of mercury (mmHg) Standard Deviation 7.04	2.2 Millimeter of mercury (mmHg) Standard Deviation 3.54
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, 24 hour	-4.0 Millimeter of mercury (mmHg) Standard Deviation 6.40	-4.8 Millimeter of mercury (mmHg) Standard Deviation 6.42	3.1 Millimeter of mercury (mmHg) Standard Deviation 8.30	-0.6 Millimeter of mercury (mmHg) Standard Deviation 6.39	-0.9 Millimeter of mercury (mmHg) Standard Deviation 2.69
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, 48 hour	-0.4 Millimeter of mercury (mmHg) Standard Deviation 6.84	-6.8 Millimeter of mercury (mmHg) Standard Deviation 5.48	-5.0 Millimeter of mercury (mmHg) Standard Deviation 3.89	-1.7 Millimeter of mercury (mmHg) Standard Deviation 4.07	-2.1 Millimeter of mercury (mmHg) Standard Deviation 4.03
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, 72 hour	-1.4 Millimeter of mercury (mmHg) Standard Deviation 5.08	-2.8 Millimeter of mercury (mmHg) Standard Deviation 8.29	4.6 Millimeter of mercury (mmHg) Standard Deviation 9.89	0.6 Millimeter of mercury (mmHg) Standard Deviation 4.24	-1.5 Millimeter of mercury (mmHg) Standard Deviation 2.95
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, Day 8	-0.3 Millimeter of mercury (mmHg) Standard Deviation 7.41	-4.8 Millimeter of mercury (mmHg) Standard Deviation 4.87	-2.7 Millimeter of mercury (mmHg) Standard Deviation 5.98	0.5 Millimeter of mercury (mmHg) Standard Deviation 6.61	0.5 Millimeter of mercury (mmHg) Standard Deviation 3.48
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 SBP, Day 30	2.7 Millimeter of mercury (mmHg) Standard Deviation 8.17	-1.7 Millimeter of mercury (mmHg) Standard Deviation 8.21	-0.1 Millimeter of mercury (mmHg) Standard Deviation 6.84	-0.9 Millimeter of mercury (mmHg) Standard Deviation 4.75	5.9 Millimeter of mercury (mmHg) Standard Deviation 3.50

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 30 days

Population: Safety Population

Pulse rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, 1 hour	0.2 Beats per minute (bpm) Standard Deviation 3.20	0.3 Beats per minute (bpm) Standard Deviation 5.49	-2.0 Beats per minute (bpm) Standard Deviation 3.19	1.5 Beats per minute (bpm) Standard Deviation 5.43	-3.2 Beats per minute (bpm) Standard Deviation 6.63
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, 2 hour	1.6 Beats per minute (bpm) Standard Deviation 3.68	4.0 Beats per minute (bpm) Standard Deviation 12.68	2.3 Beats per minute (bpm) Standard Deviation 4.54	3.8 Beats per minute (bpm) Standard Deviation 6.00	-2.3 Beats per minute (bpm) Standard Deviation 8.82
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, 4 hour	0.4 Beats per minute (bpm) Standard Deviation 5.83	-0.5 Beats per minute (bpm) Standard Deviation 7.68	-1.9 Beats per minute (bpm) Standard Deviation 3.24	0.2 Beats per minute (bpm) Standard Deviation 5.53	0.7 Beats per minute (bpm) Standard Deviation 9.37
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, 8 hour	1.5 Beats per minute (bpm) Standard Deviation 4.46	1.2 Beats per minute (bpm) Standard Deviation 4.50	1.9 Beats per minute (bpm) Standard Deviation 2.63	4.8 Beats per minute (bpm) Standard Deviation 5.89	1.3 Beats per minute (bpm) Standard Deviation 6.76
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, 12 hour	6.9 Beats per minute (bpm) Standard Deviation 12.49	1.6 Beats per minute (bpm) Standard Deviation 5.04	2.3 Beats per minute (bpm) Standard Deviation 4.19	8.6 Beats per minute (bpm) Standard Deviation 8.12	-0.7 Beats per minute (bpm) Standard Deviation 8.35
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, 24 hour	-1.9 Beats per minute (bpm) Standard Deviation 4.49	-1.6 Beats per minute (bpm) Standard Deviation 9.89	1.4 Beats per minute (bpm) Standard Deviation 7.17	-1.3 Beats per minute (bpm) Standard Deviation 5.49	-0.9 Beats per minute (bpm) Standard Deviation 10.07
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, 48 hour	1.8 Beats per minute (bpm) Standard Deviation 10.74	0.2 Beats per minute (bpm) Standard Deviation 9.79	1.4 Beats per minute (bpm) Standard Deviation 4.46	2.3 Beats per minute (bpm) Standard Deviation 5.10	-0.6 Beats per minute (bpm) Standard Deviation 6.61
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, 72 hour	3.7 Beats per minute (bpm) Standard Deviation 4.85	1.0 Beats per minute (bpm) Standard Deviation 5.26	4.0 Beats per minute (bpm) Standard Deviation 3.47	5.3 Beats per minute (bpm) Standard Deviation 5.39	0.3 Beats per minute (bpm) Standard Deviation 9.90
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, Day 8	3.5 Beats per minute (bpm) Standard Deviation 5.55	0.4 Beats per minute (bpm) Standard Deviation 6.34	1.4 Beats per minute (bpm) Standard Deviation 2.58	6.0 Beats per minute (bpm) Standard Deviation 7.36	1.5 Beats per minute (bpm) Standard Deviation 9.03
Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1 PR, Day 30	2.0 Beats per minute (bpm) Standard Deviation 6.53	4.3 Beats per minute (bpm) Standard Deviation 11.94	0.2 Beats per minute (bpm) Standard Deviation 5.36	6.3 Beats per minute (bpm) Standard Deviation 6.19	-1.1 Beats per minute (bpm) Standard Deviation 9.67

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 30 days

Population: Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

Respiratory rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, 4 hour, n=8, 6, 6, 5, 6	-0.8 Breaths per minute Standard Deviation 3.01	-0.2 Breaths per minute Standard Deviation 2.14	0.0 Breaths per minute Standard Deviation 2.90	0.4 Breaths per minute Standard Deviation 5.50	0.2 Breaths per minute Standard Deviation 3.31
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, 1 hour, n=8, 6, 6, 6, 6	-0.5 Breaths per minute Standard Deviation 2.14	-1.3 Breaths per minute Standard Deviation 1.86	0.8 Breaths per minute Standard Deviation 3.54	1.5 Breaths per minute Standard Deviation 2.59	0.7 Breaths per minute Standard Deviation 3.67
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, 2 hour, n=8, 6, 6, 6, 6	-0.3 Breaths per minute Standard Deviation 2.38	0.3 Breaths per minute Standard Deviation 3.14	-2.7 Breaths per minute Standard Deviation 2.66	1.0 Breaths per minute Standard Deviation 4.15	-1.7 Breaths per minute Standard Deviation 1.63
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, 8 hour, n=8, 6, 6, 6, 6	-0.1 Breaths per minute Standard Deviation 2.95	-0.5 Breaths per minute Standard Deviation 1.87	-1.0 Breaths per minute Standard Deviation 3.79	-1.2 Breaths per minute Standard Deviation 3.87	-2.2 Breaths per minute Standard Deviation 1.83
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, 12 hour, n=8, 6, 6, 6, 6	-0.3 Breaths per minute Standard Deviation 2.19	0.8 Breaths per minute Standard Deviation 1.60	-0.5 Breaths per minute Standard Deviation 2.59	0.0 Breaths per minute Standard Deviation 3.10	0.0 Breaths per minute Standard Deviation 1.41
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, 24 hour, n=8, 6, 6, 6, 6	-0.6 Breaths per minute Standard Deviation 2.62	-0.3 Breaths per minute Standard Deviation 2.94	-2.2 Breaths per minute Standard Deviation 3.54	0.5 Breaths per minute Standard Deviation 1.52	-0.7 Breaths per minute Standard Deviation 1.75
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, 48 hour, n=8, 6, 6, 6, 6	-0.5 Breaths per minute Standard Deviation 3.12	-0.8 Breaths per minute Standard Deviation 2.32	-2.0 Breaths per minute Standard Deviation 3.74	3.0 Breaths per minute Standard Deviation 3.29	1.7 Breaths per minute Standard Deviation 1.63
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, 72 hour, n=8, 6, 6, 6, 6	-0.5 Breaths per minute Standard Deviation 3.07	0.7 Breaths per minute Standard Deviation 3.44	0.0 Breaths per minute Standard Deviation 3.52	0.8 Breaths per minute Standard Deviation 3.66	-1.7 Breaths per minute Standard Deviation 2.25
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, Day 8, n=8, 6, 6, 6, 6	-0.6 Breaths per minute Standard Deviation 3.20	-1.3 Breaths per minute Standard Deviation 1.51	-1.5 Breaths per minute Standard Deviation 4.72	1.0 Breaths per minute Standard Deviation 2.97	-1.0 Breaths per minute Standard Deviation 2.68
Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1 RR, Day 30, n=8, 6, 6, 6, 6	1.0 Breaths per minute Standard Deviation 1.69	0.0 Breaths per minute Standard Deviation 1.41	-0.7 Breaths per minute Standard Deviation 3.44	-0.7 Breaths per minute Standard Deviation 3.50	-0.3 Breaths per minute Standard Deviation 2.25

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 30 days

Population: Safety Population

Temperature was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, 1 hour	0.06 Degree Celsius Standard Deviation 0.185	0.00 Degree Celsius Standard Deviation 0.237	0.05 Degree Celsius Standard Deviation 0.122	0.10 Degree Celsius Standard Deviation 0.276	0.10 Degree Celsius Standard Deviation 0.200
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, 2 hour	0.04 Degree Celsius Standard Deviation 0.288	-0.02 Degree Celsius Standard Deviation 0.147	0.02 Degree Celsius Standard Deviation 0.172	-0.15 Degree Celsius Standard Deviation 0.243	0.05 Degree Celsius Standard Deviation 0.243
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, 4 hour	0.14 Degree Celsius Standard Deviation 0.213	0.08 Degree Celsius Standard Deviation 0.319	0.05 Degree Celsius Standard Deviation 0.217	-0.02 Degree Celsius Standard Deviation 0.264	0.08 Degree Celsius Standard Deviation 0.194
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, 8 hour	0.24 Degree Celsius Standard Deviation 0.297	-0.02 Degree Celsius Standard Deviation 0.279	0.20 Degree Celsius Standard Deviation 0.126	0.18 Degree Celsius Standard Deviation 0.147	0.23 Degree Celsius Standard Deviation 0.288
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, 12 hour	0.18 Degree Celsius Standard Deviation 0.255	0.03 Degree Celsius Standard Deviation 0.234	-0.03 Degree Celsius Standard Deviation 0.137	0.12 Degree Celsius Standard Deviation 0.204	0.08 Degree Celsius Standard Deviation 0.232
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, 24 hour	-0.01 Degree Celsius Standard Deviation 0.290	-0.10 Degree Celsius Standard Deviation 0.167	-0.05 Degree Celsius Standard Deviation 0.152	0.07 Degree Celsius Standard Deviation 0.197	-0.03 Degree Celsius Standard Deviation 0.350
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, 48 hour	0.00 Degree Celsius Standard Deviation 0.434	-0.10 Degree Celsius Standard Deviation 0.210	0.03 Degree Celsius Standard Deviation 0.121	0.02 Degree Celsius Standard Deviation 0.248	-0.10 Degree Celsius Standard Deviation 0.276
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, 72 hour	0.06 Degree Celsius Standard Deviation 0.220	-0.07 Degree Celsius Standard Deviation 0.250	0.07 Degree Celsius Standard Deviation 0.225	0.07 Degree Celsius Standard Deviation 0.175	-0.03 Degree Celsius Standard Deviation 0.197
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, Day 8	0.00 Degree Celsius Standard Deviation 0.233	-0.08 Degree Celsius Standard Deviation 0.319	0.00 Degree Celsius Standard Deviation 0.200	-0.20 Degree Celsius Standard Deviation 0.228	0.05 Degree Celsius Standard Deviation 0.138
Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 Temperature, Day 30	-0.04 Degree Celsius Standard Deviation 0.177	-0.07 Degree Celsius Standard Deviation 0.216	0.00 Degree Celsius Standard Deviation 0.190	-0.07 Degree Celsius Standard Deviation 0.225	-0.12 Degree Celsius Standard Deviation 0.436

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 115 days

Population: Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

SBP and DBP were taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113 +- 2 days). Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 36, n=6, 6, 6, 5	-0.8 mmHg Standard Deviation 8.10	4.3 mmHg Standard Deviation 7.05	1.7 mmHg Standard Deviation 4.67	2.6 mmHg Standard Deviation 5.09	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 1, 12 hour, n=6, 6, 6, 6	-0.1 mmHg Standard Deviation 6.39	-0.4 mmHg Standard Deviation 5.32	-2.9 mmHg Standard Deviation 7.54	5.8 mmHg Standard Deviation 4.11	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 2, 24 hour, n=6, 6, 6, 6	3.0 mmHg Standard Deviation 6.25	-0.1 mmHg Standard Deviation 4.35	0.4 mmHg Standard Deviation 4.95	2.4 mmHg Standard Deviation 2.83	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 3, 48 hour, n=6, 6, 6, 6	0.7 mmHg Standard Deviation 8.69	1.5 mmHg Standard Deviation 6.13	-2.4 mmHg Standard Deviation 6.34	5.0 mmHg Standard Deviation 4.38	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 4, 72 hour, n=6, 6, 6, 6	3.9 mmHg Standard Deviation 4.96	-3.7 mmHg Standard Deviation 6.64	0.2 mmHg Standard Deviation 7.29	7.5 mmHg Standard Deviation 3.32	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 8, n=6, 6, 6, 6	-0.7 mmHg Standard Deviation 7.45	-1.7 mmHg Standard Deviation 6.25	-4.4 mmHg Standard Deviation 5.97	2.8 mmHg Standard Deviation 7.24	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 15, n=6, 6, 6, 6	3.5 mmHg Standard Deviation 10.88	4.6 mmHg Standard Deviation 7.93	-2.3 mmHg Standard Deviation 6.47	1.5 mmHg Standard Deviation 5.47	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 22, 1 hour, n=6, 6, 6, 6	1.7 mmHg Standard Deviation 6.34	-4.6 mmHg Standard Deviation 4.41	-1.6 mmHg Standard Deviation 2.20	3.2 mmHg Standard Deviation 7.34	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 22, 4 hour, n=6, 6, 6, 6	-0.3 mmHg Standard Deviation 6.11	-2.0 mmHg Standard Deviation 4.70	-4.2 mmHg Standard Deviation 5.24	2.5 mmHg Standard Deviation 4.99	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 22, 6 hour, n=6, 6, 6, 6	-2.4 mmHg Standard Deviation 7.57	-2.7 mmHg Standard Deviation 2.55	-6.1 mmHg Standard Deviation 7.77	1.3 mmHg Standard Deviation 5.49	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 22, 8 hour, n=6, 6, 6, 6	-0.3 mmHg Standard Deviation 5.73	-5.9 mmHg Standard Deviation 2.98	-5.4 mmHg Standard Deviation 6.27	0.6 mmHg Standard Deviation 4.57	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 22, 12 hour, n=6, 6, 6, 6	4.9 mmHg Standard Deviation 6.14	0.1 mmHg Standard Deviation 3.22	-5.2 mmHg Standard Deviation 8.57	5.2 mmHg Standard Deviation 4.07	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 23, 24 hour, n=6, 6, 6, 6	0.8 mmHg Standard Deviation 8.50	-5.7 mmHg Standard Deviation 3.77	-1.2 mmHg Standard Deviation 5.67	4.9 mmHg Standard Deviation 6.35	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 24, 48 hour, n=6, 6, 6, 6	0.3 mmHg Standard Deviation 3.79	-7.4 mmHg Standard Deviation 4.48	-0.8 mmHg Standard Deviation 5.02	2.8 mmHg Standard Deviation 5.29	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 25, 72 hour, n=6, 6, 6, 6	1.2 mmHg Standard Deviation 5.37	-1.0 mmHg Standard Deviation 3.48	4.4 mmHg Standard Deviation 5.69	5.0 mmHg Standard Deviation 3.87	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 29, n=6, 6, 6, 6	0.3 mmHg Standard Deviation 6.24	6.8 mmHg Standard Deviation 7.69	-1.0 mmHg Standard Deviation 4.68	1.9 mmHg Standard Deviation 5.57	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 36, n=6, 6, 6, 5	-2.8 mmHg Standard Deviation 9.99	4.2 mmHg Standard Deviation 7.35	0.7 mmHg Standard Deviation 6.11	3.2 mmHg Standard Deviation 3.89	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 50, n=6, 6, 6, 5	8.1 mmHg Standard Deviation 6.28	3.9 mmHg Standard Deviation 4.47	-0.7 mmHg Standard Deviation 7.20	2.5 mmHg Standard Deviation 2.32	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 71, n=6, 6, 6, 5	1.1 mmHg Standard Deviation 7.49	4.9 mmHg Standard Deviation 7.81	4.1 mmHg Standard Deviation 7.42	7.4 mmHg Standard Deviation 5.34	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Follow-up, n=6, 6, 6, 5	4.8 mmHg Standard Deviation 8.05	-2.1 mmHg Standard Deviation 7.16	10.0 mmHg Standard Deviation 5.98	11.5 mmHg Standard Deviation 5.29	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 1, 1 hour, n=6, 6, 6, 6	0.5 mmHg Standard Deviation 4.75	5.7 mmHg Standard Deviation 4.83	-1.8 mmHg Standard Deviation 3.49	-2.4 mmHg Standard Deviation 4.26	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 1, 2 hour, n=6, 6, 6, 6	2.1 mmHg Standard Deviation 5.56	-0.1 mmHg Standard Deviation 4.83	-0.8 mmHg Standard Deviation 6.74	-1.6 mmHg Standard Deviation 3.47	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 1, 4 hour, n=6, 6, 6, 6	-2.1 mmHg Standard Deviation 5.54	-5.1 mmHg Standard Deviation 6.25	-4.6 mmHg Standard Deviation 5.86	-8.0 mmHg Standard Deviation 3.69	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 1, 6 hour, n=6, 6, 6, 6	-5.3 mmHg Standard Deviation 5.51	-2.6 mmHg Standard Deviation 6.90	-3.5 mmHg Standard Deviation 5.03	-5.1 mmHg Standard Deviation 3.37	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 1, 8 hour, n=6, 6, 6, 6	-0.2 mmHg Standard Deviation 6.66	1.4 mmHg Standard Deviation 4.12	-3.0 mmHg Standard Deviation 8.63	-4.1 mmHg Standard Deviation 3.51	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 1, 12 hour, n=6, 6, 6, 6	-4.4 mmHg Standard Deviation 7.17	-2.6 mmHg Standard Deviation 4.49	-7.7 mmHg Standard Deviation 5.97	-4.4 mmHg Standard Deviation 4.75	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 2, 24 hour, n=6, 6, 6, 6	2.6 mmHg Standard Deviation 6.29	0.9 mmHg Standard Deviation 3.36	-3.0 mmHg Standard Deviation 4.87	-2.1 mmHg Standard Deviation 2.10	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 3, 48 hour, n=6, 6, 6, 6	-0.2 mmHg Standard Deviation 5.41	2.6 mmHg Standard Deviation 5.55	-4.8 mmHg Standard Deviation 5.24	-2.6 mmHg Standard Deviation 4.76	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 4, 72 hour, n=6, 6, 6, 6	1.6 mmHg Standard Deviation 5.77	-6.1 mmHg Standard Deviation 6.56	-1.9 mmHg Standard Deviation 3.09	-0.1 mmHg Standard Deviation 4.13	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 8, n=6, 6, 6, 6	1.6 mmHg Standard Deviation 7.61	1.9 mmHg Standard Deviation 5.59	-2.6 mmHg Standard Deviation 3.82	-3.0 mmHg Standard Deviation 5.66	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 15, n=6, 6, 6, 6	2.9 mmHg Standard Deviation 11.22	5.5 mmHg Standard Deviation 3.60	2.6 mmHg Standard Deviation 6.70	-3.1 mmHg Standard Deviation 3.82	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 22, pre-dose, n=6, 6, 6, 6	1.0 mmHg Standard Deviation 7.07	-3.8 mmHg Standard Deviation 4.91	-3.1 mmHg Standard Deviation 1.66	-2.2 mmHg Standard Deviation 2.37	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 22, 1 hour, n=6, 6, 6, 6	2.6 mmHg Standard Deviation 6.79	-0.8 mmHg Standard Deviation 7.56	-2.3 mmHg Standard Deviation 6.39	-1.8 mmHg Standard Deviation 3.44	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 22, 4 hour, n=6, 6, 6, 6	-4.0 mmHg Standard Deviation 7.53	-0.3 mmHg Standard Deviation 6.34	-4.8 mmHg Standard Deviation 6.46	-3.4 mmHg Standard Deviation 4.48	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 22, 6 hour, n=6, 6, 6, 6	-4.5 mmHg Standard Deviation 6.22	0.1 mmHg Standard Deviation 5.44	-9.3 mmHg Standard Deviation 8.96	-4.2 mmHg Standard Deviation 6.42	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 22, 8 hour, n=6, 6, 6, 6	-0.3 mmHg Standard Deviation 5.82	-2.8 mmHg Standard Deviation 6.29	-4.4 mmHg Standard Deviation 7.14	-1.2 mmHg Standard Deviation 2.55	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 22, 12 hour, n=6, 6, 6, 6	-0.1 mmHg Standard Deviation 7.80	-2.9 mmHg Standard Deviation 3.01	-7.0 mmHg Standard Deviation 9.15	-2.6 mmHg Standard Deviation 4.15	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 23, 24 hour, n=6, 6, 6, 6	0.7 mmHg Standard Deviation 8.59	-4.2 mmHg Standard Deviation 6.14	-4.5 mmHg Standard Deviation 4.00	-0.6 mmHg Standard Deviation 4.08	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 24, 48 hour, n=6, 6, 6, 6	-0.6 mmHg Standard Deviation 5.84	-2.8 mmHg Standard Deviation 5.32	-1.7 mmHg Standard Deviation 4.30	-0.9 mmHg Standard Deviation 8.38	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 25, 72 hour, n=6, 6, 6, 6	1.3 mmHg Standard Deviation 6.71	0.7 mmHg Standard Deviation 3.88	0.4 mmHg Standard Deviation 2.83	0.1 mmHg Standard Deviation 5.00	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 29, n=6, 6, 6, 6	0.6 mmHg Standard Deviation 9.06	5.7 mmHg Standard Deviation 7.45	1.1 mmHg Standard Deviation 4.70	-2.9 mmHg Standard Deviation 4.30	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 50, n=6, 6, 6, 5	5.8 mmHg Standard Deviation 3.93	9.7 mmHg Standard Deviation 7.90	2.9 mmHg Standard Deviation 4.39	-0.1 mmHg Standard Deviation 6.22	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Day 71, n=6, 6, 6, 5	3.2 mmHg Standard Deviation 6.27	8.9 mmHg Standard Deviation 6.31	2.4 mmHg Standard Deviation 3.94	4.0 mmHg Standard Deviation 2.22	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 DBP, Follow-up, n=6, 6, 6, 5	3.7 mmHg Standard Deviation 6.38	2.2 mmHg Standard Deviation 6.54	4.3 mmHg Standard Deviation 3.85	7.7 mmHg Standard Deviation 1.75	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 1, 1 hour, n=6, 6, 6, 6	1.2 mmHg Standard Deviation 5.55	3.4 mmHg Standard Deviation 6.83	1.1 mmHg Standard Deviation 5.35	5.3 mmHg Standard Deviation 4.17	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 1, 2 hour, n=6, 6, 6, 6	0.7 mmHg Standard Deviation 5.95	0.5 mmHg Standard Deviation 2.99	-0.6 mmHg Standard Deviation 3.38	3.9 mmHg Standard Deviation 8.89	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 1, 4 hour, n=6, 6, 6, 6	-2.6 mmHg Standard Deviation 6.36	-2.6 mmHg Standard Deviation 2.16	-4.6 mmHg Standard Deviation 6.57	0.4 mmHg Standard Deviation 4.28	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 1, 6 hour, n=6, 6, 6, 6	-3.6 mmHg Standard Deviation 6.23	-0.9 mmHg Standard Deviation 3.71	-1.6 mmHg Standard Deviation 6.54	5.4 mmHg Standard Deviation 6.67	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 1, 8 hour, n=6, 6, 6, 6	0.3 mmHg Standard Deviation 3.26	0.6 mmHg Standard Deviation 3.65	0.4 mmHg Standard Deviation 10.56	5.8 mmHg Standard Deviation 6.37	—
Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2 SBP, Day 22, pre-dose, n=6, 6, 6, 6	-1.1 mmHg Standard Deviation 9.18	-4.6 mmHg Standard Deviation 5.69	-4.0 mmHg Standard Deviation 2.60	-1.1 mmHg Standard Deviation 5.65	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 115 days

Population: Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

Pulse rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 1, 1 hour, n=6, 6, 6, 6	-1.5 bpm Standard Deviation 7.15	0.5 bpm Standard Deviation 3.80	0.3 bpm Standard Deviation 1.54	-2.4 bpm Standard Deviation 2.09	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 1, 2 hour, n=6, 6, 6, 6	0.4 bpm Standard Deviation 4.57	-1.6 bpm Standard Deviation 6.79	2.9 bpm Standard Deviation 4.17	-1.1 bpm Standard Deviation 3.81	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 1, 4 hour, n=6, 6, 6, 6	4.7 bpm Standard Deviation 4.13	4.6 bpm Standard Deviation 5.99	6.6 bpm Standard Deviation 3.75	2.4 bpm Standard Deviation 2.79	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 1, 6 hour, n=6, 6, 6, 6	6.4 bpm Standard Deviation 2.38	5.8 bpm Standard Deviation 7.12	7.9 bpm Standard Deviation 3.27	6.6 bpm Standard Deviation 3.93	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 1, 8 hour, n=6, 6, 6, 6	0.4 bpm Standard Deviation 1.83	3.5 bpm Standard Deviation 5.39	7.8 bpm Standard Deviation 6.99	0.5 bpm Standard Deviation 3.91	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 1, 12 hour, n=6, 6, 6, 6	4.0 bpm Standard Deviation 3.29	7.2 bpm Standard Deviation 7.13	7.8 bpm Standard Deviation 6.09	3.9 bpm Standard Deviation 4.59	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 2, 24 hour, n=6, 6, 6, 6	0.6 bpm Standard Deviation 4.62	-2.4 bpm Standard Deviation 4.84	2.4 bpm Standard Deviation 3.33	-1.1 bpm Standard Deviation 2.39	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 3, 48 hour, n=6, 6, 6, 6	3.8 bpm Standard Deviation 4.90	4.3 bpm Standard Deviation 9.58	6.2 bpm Standard Deviation 5.70	-0.1 bpm Standard Deviation 2.93	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 4, 72 hour, n=6, 6, 6, 6	10.1 bpm Standard Deviation 8.83	5.7 bpm Standard Deviation 5.30	10.8 bpm Standard Deviation 8.06	4.0 bpm Standard Deviation 7.05	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 8, n=6, 6, 6, 6	0.5 bpm Standard Deviation 3.11	1.6 bpm Standard Deviation 8.20	7.1 bpm Standard Deviation 6.86	-1.6 bpm Standard Deviation 2.55	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 15, n=6, 6, 6, 6	-0.2 bpm Standard Deviation 10.22	4.9 bpm Standard Deviation 12.25	2.4 bpm Standard Deviation 3.52	-5.7 bpm Standard Deviation 6.04	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 22, pre-dose, n=6, 6, 6, 6	2.7 bpm Standard Deviation 6.80	8.0 bpm Standard Deviation 14.84	1.5 bpm Standard Deviation 1.59	-2.9 bpm Standard Deviation 4.51	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 22, 1 hour, n=6, 6, 6, 6	1.4 bpm Standard Deviation 4.84	-3.1 bpm Standard Deviation 4.22	2.2 bpm Standard Deviation 3.35	-3.2 bpm Standard Deviation 7.19	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 22, 4 hour, n=6, 6, 6, 6	6.0 bpm Standard Deviation 4.01	4.3 bpm Standard Deviation 5.87	11.5 bpm Standard Deviation 10.74	2.6 bpm Standard Deviation 6.63	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 22, 6 hour, n=6, 6, 6, 6	7.2 bpm Standard Deviation 3.75	3.8 bpm Standard Deviation 1.81	8.6 bpm Standard Deviation 3.98	2.4 bpm Standard Deviation 5.99	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 22, 8 hour, n=6, 6, 6, 6	2.2 bpm Standard Deviation 6.26	-1.6 bpm Standard Deviation 5.59	5.7 bpm Standard Deviation 3.61	-2.1 bpm Standard Deviation 5.06	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 22, 12 hour, n=6, 6, 6, 6	6.4 bpm Standard Deviation 4.03	5.4 bpm Standard Deviation 4.64	9.3 bpm Standard Deviation 4.47	7.9 bpm Standard Deviation 7.02	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 23, 24 hour, n=6, 6, 6, 6	3.6 bpm Standard Deviation 3.46	0.0 bpm Standard Deviation 4.92	4.6 bpm Standard Deviation 6.63	0.7 bpm Standard Deviation 7.64	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 24, 48 hour, n=6, 6, 6, 6	4.1 bpm Standard Deviation 2.88	-1.0 bpm Standard Deviation 4.85	3.6 bpm Standard Deviation 3.79	2.9 bpm Standard Deviation 9.40	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 25, 72 hour, n=6, 6, 6, 6	8.7 bpm Standard Deviation 10.05	7.1 bpm Standard Deviation 5.05	7.0 bpm Standard Deviation 4.94	4.3 bpm Standard Deviation 7.77	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 29, n=6, 6, 6, 6	8.4 bpm Standard Deviation 4.76	6.9 bpm Standard Deviation 8.33	5.0 bpm Standard Deviation 1.14	-0.6 bpm Standard Deviation 7.41	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 36, n=6, 6, 6, 5	4.1 bpm Standard Deviation 6.54	5.4 bpm Standard Deviation 7.51	3.8 bpm Standard Deviation 6.10	-3.2 bpm Standard Deviation 13.57	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 50, n=6, 6, 6, 5	9.9 bpm Standard Deviation 4.85	1.1 bpm Standard Deviation 2.09	2.2 bpm Standard Deviation 6.51	-7.0 bpm Standard Deviation 6.34	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Day 71, n=6, 6, 6, 5	6.1 bpm Standard Deviation 2.74	5.1 bpm Standard Deviation 7.39	6.0 bpm Standard Deviation 2.04	-1.9 bpm Standard Deviation 6.93	—
Change From Baseline in PR at the Indicated Time Points in Part 2 PR, Follow-up, n=6, 6, 6, 5	6.1 bpm Standard Deviation 6.79	2.7 bpm Standard Deviation 5.08	6.0 bpm Standard Deviation 4.23	2.0 bpm Standard Deviation 5.71	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 115 days

Population: Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

Respiratory rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 29, n=6, 6, 6, 6	0.7 Breaths per minute Standard Deviation 1.63	1.3 Breaths per minute Standard Deviation 2.73	-1.0 Breaths per minute Standard Deviation 1.67	-0.2 Breaths per minute Standard Deviation 1.33	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 1, 1 hour, n=6, 6, 6, 6	-0.3 Breaths per minute Standard Deviation 1.97	0.7 Breaths per minute Standard Deviation 2.73	0.0 Breaths per minute Standard Deviation 1.26	0.5 Breaths per minute Standard Deviation 1.97	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 1, 2 hour, n=6, 6, 6, 6	-0.3 Breaths per minute Standard Deviation 1.97	-0.3 Breaths per minute Standard Deviation 2.34	0.7 Breaths per minute Standard Deviation 1.63	0.5 Breaths per minute Standard Deviation 1.22	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 1, 4 hour, n=6, 6, 6, 6	0.0 Breaths per minute Standard Deviation 3.35	1.0 Breaths per minute Standard Deviation 3.52	-0.7 Breaths per minute Standard Deviation 2.42	-0.5 Breaths per minute Standard Deviation 0.84	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 1, 6 hour, n=6, 6, 6, 6	-0.3 Breaths per minute Standard Deviation 2.66	1.3 Breaths per minute Standard Deviation 4.13	2.0 Breaths per minute Standard Deviation 2.53	-0.5 Breaths per minute Standard Deviation 0.84	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 1, 8 hour, n=6, 6, 6, 6	-0.7 Breaths per minute Standard Deviation 2.73	1.3 Breaths per minute Standard Deviation 3.01	0.7 Breaths per minute Standard Deviation 2.42	0.8 Breaths per minute Standard Deviation 1.83	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 2, 24 hour, n=6, 6, 6, 6	0.7 Breaths per minute Standard Deviation 2.42	1.0 Breaths per minute Standard Deviation 2.10	-1.7 Breaths per minute Standard Deviation 1.51	-0.5 Breaths per minute Standard Deviation 0.84	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 8, n=6, 6, 6, 6	1.3 Breaths per minute Standard Deviation 1.63	-0.3 Breaths per minute Standard Deviation 3.88	1.3 Breaths per minute Standard Deviation 3.72	-0.8 Breaths per minute Standard Deviation 3.13	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 22, 1 hour, n=6, 6, 6, 6	0.7 Breaths per minute Standard Deviation 3.27	0.3 Breaths per minute Standard Deviation 3.88	-0.3 Breaths per minute Standard Deviation 3.88	0.5 Breaths per minute Standard Deviation 1.52	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 22, 6 hour, n=6, 6, 6, 6	1.0 Breaths per minute Standard Deviation 2.10	2.3 Breaths per minute Standard Deviation 3.88	3.0 Breaths per minute Standard Deviation 2.76	0.2 Breaths per minute Standard Deviation 2.56	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 22, 8 hour, n=6, 6, 6, 6	1.7 Breaths per minute Standard Deviation 1.97	2.7 Breaths per minute Standard Deviation 3.50	-0.7 Breaths per minute Standard Deviation 2.07	-0.8 Breaths per minute Standard Deviation 1.83	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 23, 24 hour, n=6, 6, 6, 6	0.7 Breaths per minute Standard Deviation 3.50	1.3 Breaths per minute Standard Deviation 2.73	-0.3 Breaths per minute Standard Deviation 2.94	-0.5 Breaths per minute Standard Deviation 0.84	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 24, 48 hour, n=6, 6, 6, 6	1.0 Breaths per minute Standard Deviation 3.03	1.7 Breaths per minute Standard Deviation 2.94	-0.3 Breaths per minute Standard Deviation 2.66	-0.5 Breaths per minute Standard Deviation 2.66	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 25, 72 hour, n=6, 6, 6, 6	1.0 Breaths per minute Standard Deviation 2.76	2.7 Breaths per minute Standard Deviation 2.42	-0.7 Breaths per minute Standard Deviation 3.01	-1.5 Breaths per minute Standard Deviation 1.22	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 36, n=6, 6, 6, 5	0.0 Breaths per minute Standard Deviation 3.10	0.7 Breaths per minute Standard Deviation 3.27	0.0 Breaths per minute Standard Deviation 3.35	-1.0 Breaths per minute Standard Deviation 1.73	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 71, n=6, 6, 6, 5	0.2 Breaths per minute Standard Deviation 2.40	1.3 Breaths per minute Standard Deviation 1.03	0.0 Breaths per minute Standard Deviation 4.00	0.6 Breaths per minute Standard Deviation 1.34	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 1, 12 hour, n=6, 6, 6, 6	2.0 Breaths per minute Standard Deviation 3.79	1.7 Breaths per minute Standard Deviation 2.66	3.3 Breaths per minute Standard Deviation 2.42	0.5 Breaths per minute Standard Deviation 2.95	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 3, 48 hour, n=6, 6, 6, 6	-1.0 Breaths per minute Standard Deviation 2.10	-0.3 Breaths per minute Standard Deviation 2.34	-1.0 Breaths per minute Standard Deviation 2.76	-0.8 Breaths per minute Standard Deviation 1.60	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 4, 72 hour, n=6, 6, 6, 6	0.8 Breaths per minute Standard Deviation 2.71	1.3 Breaths per minute Standard Deviation 3.67	0.3 Breaths per minute Standard Deviation 3.44	-0.2 Breaths per minute Standard Deviation 1.33	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 15, n=6, 6, 6, 6	0.7 Breaths per minute Standard Deviation 1.63	1.5 Breaths per minute Standard Deviation 1.76	0.7 Breaths per minute Standard Deviation 2.42	-0.8 Breaths per minute Standard Deviation 3.13	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 22, pre-dose, n=6, 6, 6, 6	0.0 Breaths per minute Standard Deviation 1.79	0.7 Breaths per minute Standard Deviation 2.42	-1.0 Breaths per minute Standard Deviation 2.45	-0.5 Breaths per minute Standard Deviation 1.97	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 22, 4 hour, n=6, 6, 6, 6	-0.7 Breaths per minute Standard Deviation 1.63	1.8 Breaths per minute Standard Deviation 4.02	-1.0 Breaths per minute Standard Deviation 3.74	0.8 Breaths per minute Standard Deviation 0.98	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 22, 12 hour, n=6, 6, 6, 6	2.3 Breaths per minute Standard Deviation 3.20	4.3 Breaths per minute Standard Deviation 3.20	1.0 Breaths per minute Standard Deviation 2.10	-1.5 Breaths per minute Standard Deviation 2.35	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Day 50, n=6, 6, 6, 5	0.5 Breaths per minute Standard Deviation 3.56	1.0 Breaths per minute Standard Deviation 3.74	-0.7 Breaths per minute Standard Deviation 3.27	-0.2 Breaths per minute Standard Deviation 1.48	—
Change From Baseline in RR at the Indicated Time Points in Part 2 RR, Follow-up, n=6, 6, 6, 5	-1.7 Breaths per minute Standard Deviation 1.51	-1.0 Breaths per minute Standard Deviation 1.67	-0.7 Breaths per minute Standard Deviation 3.50	0.6 Breaths per minute Standard Deviation 2.61	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 115 days

Population: Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

Body temperature was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 1, 1 hour, n=6, 6, 6, 6	0.27 Degree Celsius Standard Deviation 0.388	0.15 Degree Celsius Standard Deviation 0.288	-0.05 Degree Celsius Standard Deviation 0.176	0.02 Degree Celsius Standard Deviation 0.440	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 1, 2 hour, n=6, 6, 6, 6	0.20 Degree Celsius Standard Deviation 0.167	-0.02 Degree Celsius Standard Deviation 0.256	0.05 Degree Celsius Standard Deviation 0.187	-0.02 Degree Celsius Standard Deviation 0.240	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 1, 6 hour, n=6, 6, 6, 6	0.28 Degree Celsius Standard Deviation 0.325	0.38 Degree Celsius Standard Deviation 0.454	0.10 Degree Celsius Standard Deviation 0.237	0.20 Degree Celsius Standard Deviation 0.358	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 1, 8 hour, n=6, 6, 6, 6	0.20 Degree Celsius Standard Deviation 0.228	0.43 Degree Celsius Standard Deviation 0.408	-0.13 Degree Celsius Standard Deviation 0.320	0.33 Degree Celsius Standard Deviation 0.557	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 1, 12 hour, n=6, 6, 6, 6	0.22 Degree Celsius Standard Deviation 0.147	0.50 Degree Celsius Standard Deviation 0.369	-0.15 Degree Celsius Standard Deviation 0.295	0.20 Degree Celsius Standard Deviation 0.390	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 2, 24 hour, n=6, 6, 6, 6	0.05 Degree Celsius Standard Deviation 0.321	-0.10 Degree Celsius Standard Deviation 0.379	-0.18 Degree Celsius Standard Deviation 0.223	-0.15 Degree Celsius Standard Deviation 0.138	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 3, 48 hour, n=6, 6, 6, 6	0.05 Degree Celsius Standard Deviation 0.442	0.15 Degree Celsius Standard Deviation 0.489	-0.22 Degree Celsius Standard Deviation 0.204	-0.32 Degree Celsius Standard Deviation 0.313	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 4, 72 hour, n=6, 6, 6, 6	-0.05 Degree Celsius Standard Deviation 0.362	0.28 Degree Celsius Standard Deviation 0.595	0.30 Degree Celsius Standard Deviation 0.210	-0.02 Degree Celsius Standard Deviation 0.417	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 8, n=6, 6, 6, 6	0.02 Degree Celsius Standard Deviation 0.436	0.05 Degree Celsius Standard Deviation 0.235	0.10 Degree Celsius Standard Deviation 0.283	-0.20 Degree Celsius Standard Deviation 0.424	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 15, n=6, 6, 6, 6	-0.23 Degree Celsius Standard Deviation 0.446	0.08 Degree Celsius Standard Deviation 0.376	-0.05 Degree Celsius Standard Deviation 0.197	-0.12 Degree Celsius Standard Deviation 0.366	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 22, pre-dose, n=6, 6, 6, 6	0.08 Degree Celsius Standard Deviation 0.488	-0.02 Degree Celsius Standard Deviation 0.331	-0.22 Degree Celsius Standard Deviation 0.183	-0.23 Degree Celsius Standard Deviation 0.082	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 22, 6 hour, n=6, 6, 6, 6	0.22 Degree Celsius Standard Deviation 0.306	0.28 Degree Celsius Standard Deviation 0.248	0.17 Degree Celsius Standard Deviation 0.163	-0.02 Degree Celsius Standard Deviation 0.293	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 22, 8 hour, n=6, 6, 6, 6	0.25 Degree Celsius Standard Deviation 0.217	0.23 Degree Celsius Standard Deviation 0.367	-0.05 Degree Celsius Standard Deviation 0.243	-0.02 Degree Celsius Standard Deviation 0.214	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 22, 12 hour, n=6, 6, 6, 6	0.22 Degree Celsius Standard Deviation 0.366	0.08 Degree Celsius Standard Deviation 0.299	0.27 Degree Celsius Standard Deviation 0.344	0.22 Degree Celsius Standard Deviation 0.147	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 23, 24 hour, n=6, 6, 6, 6	0.18 Degree Celsius Standard Deviation 0.366	0.15 Degree Celsius Standard Deviation 0.536	-0.13 Degree Celsius Standard Deviation 0.216	-0.12 Degree Celsius Standard Deviation 0.279	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 25, 72 hour, n=6, 6, 6, 6	0.10 Degree Celsius Standard Deviation 0.276	0.20 Degree Celsius Standard Deviation 0.562	0.12 Degree Celsius Standard Deviation 0.445	-0.20 Degree Celsius Standard Deviation 0.276	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 29, n=6, 6, 6, 6	-0.38 Degree Celsius Standard Deviation 0.366	-0.05 Degree Celsius Standard Deviation 0.187	-0.15 Degree Celsius Standard Deviation 0.266	-0.23 Degree Celsius Standard Deviation 0.250	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 50, n=6, 6, 6, 5	0.02 Degree Celsius Standard Deviation 0.325	-0.07 Degree Celsius Standard Deviation 0.480	-0.37 Degree Celsius Standard Deviation 0.121	0.04 Degree Celsius Standard Deviation 0.416	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Follow-up, n=6, 6, 6, 5	-0.18 Degree Celsius Standard Deviation 0.479	0.08 Degree Celsius Standard Deviation 0.397	-0.12 Degree Celsius Standard Deviation 0.293	-0.02 Degree Celsius Standard Deviation 0.259	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 24, 48 hour, n=6, 6, 6, 6	0.12 Degree Celsius Standard Deviation 0.417	0.00 Degree Celsius Standard Deviation 0.352	-0.08 Degree Celsius Standard Deviation 0.098	-0.13 Degree Celsius Standard Deviation 0.432	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 36, n=6, 6, 6, 5	0.22 Degree Celsius Standard Deviation 0.271	0.03 Degree Celsius Standard Deviation 0.350	-0.20 Degree Celsius Standard Deviation 0.385	-0.16 Degree Celsius Standard Deviation 0.378	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 1, 4 hour, n=6, 6, 6, 6	0.40 Degree Celsius Standard Deviation 0.110	0.35 Degree Celsius Standard Deviation 0.308	0.02 Degree Celsius Standard Deviation 0.117	0.15 Degree Celsius Standard Deviation 0.432	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 71, n=6, 6, 6, 5	-0.18 Degree Celsius Standard Deviation 0.286	-0.13 Degree Celsius Standard Deviation 0.378	-0.53 Degree Celsius Standard Deviation 0.280	-0.34 Degree Celsius Standard Deviation 0.305	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 22, 1 hour, n=6, 6, 6, 6	0.15 Degree Celsius Standard Deviation 0.266	-0.15 Degree Celsius Standard Deviation 0.315	-0.07 Degree Celsius Standard Deviation 0.175	-0.20 Degree Celsius Standard Deviation 0.303	—
Change From Baseline in Body Temperature at the Indicated Time Points in Part 2 Temperature, Day 22, 4 hour, n=6, 6, 6, 6	0.38 Degree Celsius Standard Deviation 0.422	0.13 Degree Celsius Standard Deviation 0.513	0.07 Degree Celsius Standard Deviation 0.242	-0.18 Degree Celsius Standard Deviation 0.366	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and up to 31 days

Population: Safety Population

12-lead ECGs were recorded at Baseline (Day 1, pre-dose) and at 1, 4, 8, 12, 24 and 48 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants with worst change from Baseline in ECG have been presented as clinically significant (CS) change or not a clinically significant (NCS) change.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=8 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 Participants Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Number of Participants With 12-lead Electrocardiogram (ECG) Findings in Part 1 CS	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With 12-lead Electrocardiogram (ECG) Findings in Part 1 NCS	2 Participants	0 Participants	1 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate AUC (0-inf), AUC (0-t) and AUC (0-24) of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose. Pharmacokinetic Concentration Population was defined as participants who underwent plasma PK sampling and had evaluable PK assay results post-dose.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=5 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Area Under the Plasma Concentration Curve (AUC) From Time Zero to Infinity [AUC (0-inf)], AUC From Time Zero to the Time of Last Quantifiable Concentration [AUC(0-t)], AUC From Time Zero to 24 Hours [AUC(0-24)] of GSK3389404 After Single Dose in Part 1 AUC (0-inf)	632 Nanogramhour per milliliter(nghour/mL) Standard Deviation 171.59	2080 Nanogramhour per milliliter(nghour/mL) Standard Deviation 801.85	4750 Nanogramhour per milliliter(nghour/mL) Standard Deviation 1450.8	8150 Nanogramhour per milliliter(nghour/mL) Standard Deviation 3204.5	—
Area Under the Plasma Concentration Curve (AUC) From Time Zero to Infinity [AUC (0-inf)], AUC From Time Zero to the Time of Last Quantifiable Concentration [AUC(0-t)], AUC From Time Zero to 24 Hours [AUC(0-24)] of GSK3389404 After Single Dose in Part 1 AUC (0-t)	484 Nanogramhour per milliliter(nghour/mL) Standard Deviation 80.962	1770 Nanogramhour per milliliter(nghour/mL) Standard Deviation 961.03	3710 Nanogramhour per milliliter(nghour/mL) Standard Deviation 1485.6	7440 Nanogramhour per milliliter(nghour/mL) Standard Deviation 2844.8	—
Area Under the Plasma Concentration Curve (AUC) From Time Zero to Infinity [AUC (0-inf)], AUC From Time Zero to the Time of Last Quantifiable Concentration [AUC(0-t)], AUC From Time Zero to 24 Hours [AUC(0-24)] of GSK3389404 After Single Dose in Part 1 AUC (0-24)	592 Nanogramhour per milliliter(nghour/mL) Standard Deviation 105.91	1970 Nanogramhour per milliliter(nghour/mL) Standard Deviation 855.08	4330 Nanogramhour per milliliter(nghour/mL) Standard Deviation 1313.5	7950 Nanogramhour per milliliter(nghour/mL) Standard Deviation 3264.9	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate Cmax, C24 and C168 of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=5 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Maximum Observed Concentration (Cmax), Observed Concentration at 24 Hours (C24) and at 168 Hours (C168) of GSK3389404 Following Single Dose in Part 1 Cmax	92.5 ng/mL Standard Deviation 23.622	350 ng/mL Standard Deviation 257.48	584 ng/mL Standard Deviation 366.96	889 ng/mL Standard Deviation 496.73	—
Maximum Observed Concentration (Cmax), Observed Concentration at 24 Hours (C24) and at 168 Hours (C168) of GSK3389404 Following Single Dose in Part 1 C24	0.00 ng/mL Standard Deviation 0.0000	0.00 ng/mL Standard Deviation 0.0000	3.33 ng/mL Standard Deviation 8.1650	18.7 ng/mL Standard Deviation 17.781	—
Maximum Observed Concentration (Cmax), Observed Concentration at 24 Hours (C24) and at 168 Hours (C168) of GSK3389404 Following Single Dose in Part 1 C168	0.00 ng/mL Standard Deviation 0.0000	0.00 ng/mL Standard Deviation 0.0000	0.00 ng/mL Standard Deviation 0.0000	0.00 ng/mL Standard Deviation 0.0000	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=5 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Time to Maximum Observed Concentration (Tmax), Terminal Half-life (T1/2) and Lag Time (Tlag) of GSK3389404 Following Single Dose in Part 1 Tlag	0.00 Hour Standard Deviation 0.00	0.00 Hour Standard Deviation 0.00	0.00 Hour Standard Deviation 0.00	0.00 Hour Standard Deviation 0.00	—
Time to Maximum Observed Concentration (Tmax), Terminal Half-life (T1/2) and Lag Time (Tlag) of GSK3389404 Following Single Dose in Part 1 Tmax	1.60 Hour Standard Deviation 1.20	1.74 Hour Standard Deviation 0.48	2.67 Hour Standard Deviation 1.37	3.83 Hour Standard Deviation 0.41	—
Time to Maximum Observed Concentration (Tmax), Terminal Half-life (T1/2) and Lag Time (Tlag) of GSK3389404 Following Single Dose in Part 1 T1/2	4.55 Hour Standard Deviation 3.3937	4.67 Hour Standard Deviation 3.5530	6.07 Hour Standard Deviation 3.9531	4.27 Hour Standard Deviation 1.2281	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate CL/F of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=5 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 Participants Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Apparent SC Plasma Clearance (CL/F) of GSK3389404 Following Single Dose in Part 1	16.8 Liter per hour Standard Deviation 4.2805	15.8 Liter per hour Standard Deviation 4.6710	13.6 Liter per hour Standard Deviation 3.6934	16.2 Liter per hour Standard Deviation 4.7050	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose

Population: Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

Blood samples were collected to evaluate AUC (0-t), AUC (0-24), AUC (0-168) and AUC (0-inf) of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
AUC (0-t), AUC(0-24), AUC From Time Zero to 168 Hours Post-dose [AUC(0-168)] and AUC (0-inf) of GSK3389404 Following Single Dose on Day 1 of Part 2 AUC (0-t), n=6, 6, 6	1300 ng*hour/mL Standard Deviation 286.51	4150 ng*hour/mL Standard Deviation 1103.1	7970 ng*hour/mL Standard Deviation 3082.7	—	—
AUC (0-t), AUC(0-24), AUC From Time Zero to 168 Hours Post-dose [AUC(0-168)] and AUC (0-inf) of GSK3389404 Following Single Dose on Day 1 of Part 2 AUC (0-24), n=6, 5, 6	1410 ng*hour/mL Standard Deviation 292.51	4940 ng*hour/mL Standard Deviation 1131.6	8330 ng*hour/mL Standard Deviation 3363.3	—	—
AUC (0-t), AUC(0-24), AUC From Time Zero to 168 Hours Post-dose [AUC(0-168)] and AUC (0-inf) of GSK3389404 Following Single Dose on Day 1 of Part 2 AUC (0-168), n=6, 5, 6	1420 ng*hour/mL Standard Deviation 291.72	5080 ng*hour/mL Standard Deviation 1332.6	8480 ng*hour/mL Standard Deviation 3249.8	—	—
AUC (0-t), AUC(0-24), AUC From Time Zero to 168 Hours Post-dose [AUC(0-168)] and AUC (0-inf) of GSK3389404 Following Single Dose on Day 1 of Part 2 AUC (0-inf), n=6, 5, 6	1420 ng*hour/mL Standard Deviation 291.72	5080 ng*hour/mL Standard Deviation 1328.9	8480 ng*hour/mL Standard Deviation 3249.8	—	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate Cmax, C24 and C168 of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Cmax, C24 and C168 of GSK3389404 Following Single Dose on Day 1 of Part 2 Cmax	236 ng/mL Standard Deviation 64.551	723 ng/mL Standard Deviation 216.01	1280 ng/mL Standard Deviation 633.56	—	—
Cmax, C24 and C168 of GSK3389404 Following Single Dose on Day 1 of Part 2 C24	0.00 ng/mL Standard Deviation 0.0000	2.58 ng/mL Standard Deviation 6.3278	16.7 ng/mL Standard Deviation 20.848	—	—
Cmax, C24 and C168 of GSK3389404 Following Single Dose on Day 1 of Part 2 C168	0.00 ng/mL Standard Deviation 0.0000	0.00 ng/mL Standard Deviation 0.0000	0.00 ng/mL Standard Deviation 0.0000	—	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose

Population: Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Tmax, T1/2 and Tlag of GSK3389404 Following Single Dose on Day 1 of Part 2 Tmax, n=6, 6, 6	2.33 Hour Standard Deviation 1.03	2.01 Hour Standard Deviation 0.02	2.42 Hour Standard Deviation 0.92	—	—
Tmax, T1/2 and Tlag of GSK3389404 Following Single Dose on Day 1 of Part 2 T1/2, n=6, 5, 6	3.14 Hour Standard Deviation 1.0621	3.47 Hour Standard Deviation 1.8907	4.04 Hour Standard Deviation 1.7867	—	—
Tmax, T1/2 and Tlag of GSK3389404 Following Single Dose on Day 1 of Part 2 Tlag, n=6, 6, 6	0.00 Hour Standard Deviation 0.00	0.00 Hour Standard Deviation 0.00	0.00 Hour Standard Deviation 0.00	—	—

PRIMARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate CL/F of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=5 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
CL/F of GSK3389404 Following Single Dose on Day 1 of Part 2	22.1 Liter per hour Standard Deviation 5.9872	12.5 Liter per hour Standard Deviation 3.4120	15.6 Liter per hour Standard Deviation 4.7861	—	—

PRIMARY outcome

Timeframe: Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate AUC (0-24) and AUC (0-tau) of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days ).

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
AUC(0-24) and AUC From Time Zero to the End of the Dosing Interval [AUC(0-tau)] of GSK3389404 Following Dosing on Day 22 of Part 2 AUC (0-24)	1486 ng*hour/mL Standard Deviation 364.92	3973 ng*hour/mL Standard Deviation 906.81	8918 ng*hour/mL Standard Deviation 3447.7	—	—
AUC(0-24) and AUC From Time Zero to the End of the Dosing Interval [AUC(0-tau)] of GSK3389404 Following Dosing on Day 22 of Part 2 AUC (0-tau)	1598 ng*hour/mL Standard Deviation 565.02	4052 ng*hour/mL Standard Deviation 873.65	9047 ng*hour/mL Standard Deviation 3361.3	—	—

PRIMARY outcome

Timeframe: Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate Ctau, C24 and Cmax of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days ).

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Observed Concentration at the End of the Dosing Interval (Ctau), C24 and Cmax of GSK3389404 Following Dosing on Day 22 of Part 2 Cmax	197.7 ng/mL Standard Deviation 39.657	614.8 ng/mL Standard Deviation 211.25	1257 ng/mL Standard Deviation 799.88	—	—
Observed Concentration at the End of the Dosing Interval (Ctau), C24 and Cmax of GSK3389404 Following Dosing on Day 22 of Part 2 Ctau	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	—	—
Observed Concentration at the End of the Dosing Interval (Ctau), C24 and Cmax of GSK3389404 Following Dosing on Day 22 of Part 2 C24	0.000 ng/mL Standard Deviation 0.0000	4.767 ng/mL Standard Deviation 7.4115	15.60 ng/mL Standard Deviation 18.278	—	—

PRIMARY outcome

Timeframe: Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Tmax, T1/2 and Tlag of GSK3389404 Following Dosing on Day 22 of Part 2 Tmax	2.17 Hour Standard Deviation 0.98	2.26 Hour Standard Deviation 0.88	2.67 Hour Standard Deviation 1.03	—	—
Tmax, T1/2 and Tlag of GSK3389404 Following Dosing on Day 22 of Part 2 T1/2	4.768 Hour Standard Deviation 3.2072	3.450 Hour Standard Deviation 1.6049	3.585 Hour Standard Deviation 1.2332	—	—
Tmax, T1/2 and Tlag of GSK3389404 Following Dosing on Day 22 of Part 2 Tlag	0.00 Hour Standard Deviation 0.00	0.00 Hour Standard Deviation 0.00	0.00 Hour Standard Deviation 0.00	—	—

PRIMARY outcome

Timeframe: Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)

Population: Pharmacokinetic Concentration Population

Blood samples were collected to evaluate Cl/F of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Cl/F of GSK3389404 Following Dosing on Day 22 of Part 2	20.50 Liter per hour Standard Deviation 6.3906	15.48 Liter per hour Standard Deviation 3.6973	14.39 Liter per hour Standard Deviation 3.7029	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose; Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose in Part 2.

Population: Pharmacokinetic Concentration Population (combined for Part 1 and 2). Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

Results of dose proportionality assessment using power model and analysis of variance (ANOVA) following single dose administariton (Part 1 and Day 1 in Part 2) are presented. Slope estimates and 90% confidence interval are presented for combined data of Day 1 of Part 1 and 2.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=41 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Dose Proportionality of GSK202007 for Dose Range 10 mg - 120 mg After Single Dose Administrations AUC (0-24), n=40	1.08 ratio Interval 0.98 to 1.18	—	—	—	—
Dose Proportionality of GSK202007 for Dose Range 10 mg - 120 mg After Single Dose Administrations AUC (0-inf), n=40	1.07 ratio Interval 0.97 to 1.18	—	—	—	—
Dose Proportionality of GSK202007 for Dose Range 10 mg - 120 mg After Single Dose Administrations Cmax, n=41	0.975 ratio Interval 0.83 to 1.12	—	—	—	—

SECONDARY outcome

Timeframe: Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115) in Part 2

Population: Pharmacokinetic Concentration Population

Results of proportionality assessment using power model and ANOVA following multiple doses are presented. Slope estimates and 90% confidence interval are presented for Day 22 of Part 2.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=18 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Dose Proportionality of GSK202007 for Dose Range 30 mg - 120 mg After Multiple Dose Administrations AUC (0-tau)	1.25 ratio Interval 1.04 to 1.46	—	—	—	—
Dose Proportionality of GSK202007 for Dose Range 30 mg - 120 mg After Multiple Dose Administrations Cmax	1.25 ratio Interval 0.96 to 1.55	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose; Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)

Population: Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).

For Part 2, the extent of accumulation of GSK3389404 was evaluated by comparing AUC (0-tau), Cmax, C24 and Ctau on Day 22 to AUC (0-168), Cmax, C24 and C168 on Day 1. For each dose level, a linear mixed effect model was fitted with the log transformed PK parameter as the dependent variable, day as a fixed effect and subject as a random effect.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Accumulation Ratio by AUC (RAUC), by Cmax (RCmax), by C24 (RC24) and by Ctau (RCtau) of GSK3389404 in Part 2 RAUC, n=6, 5, 6	1.115 Ratio Standard Deviation 0.24879	0.8596 Ratio Standard Deviation 0.099034	1.094 Ratio Standard Deviation 0.24035	—	—
Accumulation Ratio by AUC (RAUC), by Cmax (RCmax), by C24 (RC24) and by Ctau (RCtau) of GSK3389404 in Part 2 RCmax, n=6, 6, 6	0.8683 Ratio Standard Deviation 0.16676	0.8518 Ratio Standard Deviation 0.18537	0.9920 Ratio Standard Deviation 0.32054	—	—
Accumulation Ratio by AUC (RAUC), by Cmax (RCmax), by C24 (RC24) and by Ctau (RCtau) of GSK3389404 in Part 2 RC24, n=0, 1, 3	—	0.8580 Ratio Standard Deviation NA Only one participant was analyzed at this endpoint, hence standard deviation could not be calculated.	0.5890 Ratio Standard Deviation 0.51139	—	—

SECONDARY outcome

Timeframe: Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose; Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)

Population: Pharmacokinetic Concentration Population

For Part 2, time invariance was evaluated by comparing AUC (0-tau) for Day 22 to AUC (0-inf) for Day 1. For each dose level, a linear mixed effect model was fitted with the log transformed PK parameter as the dependent variable, day as a fixed effect and subject as a random effect. Only those participants with data available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=5 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Time Invariance (LI) of GSK3389404 in Part 2	1.115 Ratio Standard Deviation 0.24879	0.8598 Ratio Standard Deviation 0.098644	1.094 Ratio Standard Deviation 0.24035	—	—

SECONDARY outcome

Timeframe: Pre-dose on Days 8, 15, 22 and 29

Population: Pharmacokinetic Concentration Population

For Part 2, mean plasma GSK3389404 pre-dose values between Day 1 to Day 29 and Ctau were plotted against time to assess attainment of GSK3389404 steady state following multiple dose administration. Achievement of plasma GSK3389404 steady-state was assessed by calculating the 90% confidence interval (CI) of the slope of the linear regression of log (Ctau) versus time. NA indicates data was not available.

Outcome measures

Outcome measures
Measure	Part 1: Placebo n=6 Participants Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 Participants Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 Participants Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.
Trough Plasma Concentrations of GSK3389404 in Part 2 Day 8	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	—	—
Trough Plasma Concentrations of GSK3389404 in Part 2 Day 15	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	—	—
Trough Plasma Concentrations of GSK3389404 in Part 2 Day 22	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	—	—
Trough Plasma Concentrations of GSK3389404 in Part 2 Day 29	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	NA Ratio Standard Deviation NA Trough plasma concentrations were below limit of quantification, hence data was not available.	—	—

Deaths: 0 deaths

Part 2: GSK3389404 120 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part 1: Placebo n=8 participants at risk Participant received a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg.	Part 1: GSK3389404 10 mg n=6 participants at risk Participants received a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 30 mg n=6 participants at risk Participants received a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 60 mg n=6 participants at risk Participants received a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1.	Part 1: GSK3389404 120 mg n=6 participants at risk Participants received a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1.	Part 2: Placebo n=6 participants at risk Participant received a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2.	Part 2: GSK3389404 30 mg n=6 participants at risk Participants received a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2.	Part 2: GSK3389404 60 mg n=6 participants at risk Participants received a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2.	Part 2: GSK3389404 120 mg n=6 participants at risk Participants received a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.
Eye disorders Eyelid irritation	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
General disorders Catheter site haematoma	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
General disorders Injection site bruising	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	33.3% 2/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
General disorders Injection site erythema	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	33.3% 2/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	33.3% 2/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	33.3% 2/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
General disorders Injection site pain	12.5% 1/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Infections and infestations Gastroenteritis	12.5% 1/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Infections and infestations Oral herpes	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Infections and infestations Viral upper respiratory tract infection	12.5% 1/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	50.0% 3/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Investigations Alanine aminotransferase increased	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Investigations Blood creatine phosphokinase increased	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Investigations Hepatic enzyme increased	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Nervous system disorders Headache	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	33.3% 2/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	33.3% 2/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	33.3% 2/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Nervous system disorders Presyncope	12.5% 1/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Gastrointestinal disorders Food poisoning	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
General disorders Injection site discomfort	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
General disorders Injection site pruritus	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
General disorders Injection site swelling	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Infections and infestations Herpes virus infection	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Infections and infestations Nasopharyngitis	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	50.0% 3/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Nervous system disorders Dizziness	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Nervous system disorders Somnolence	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of the study treatment up to 62 days in Part 1 and up to 115 days in Part 2. On treatment SAEs and non-serious AEs were reported for the Safety Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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