Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants (NCT NCT04366349)

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

65 participants

Primary outcome timeframe

Up to Day 85

Results posted on

2021-11-05

Participant Flow

Participants who met the eligibility criteria were assigned to one of the four cohorts and were randomly allocated within each cohort to receive a single dose of either GSK3772847 or placebo. All treatments were administered subcutaneously. The site of injection was randomized to the upper arm, abdomen, or thigh for cohorts 1 and 2. Injection was given in the upper arm only in cohorts 3 and 4.

A total of 65 participants were enrolled in this study.

Participant milestones

Participant milestones
Measure	Cohorts 1 and 2: Placebo SC Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Overall Study STARTED	13	18	18	4	6	6
Overall Study COMPLETED	12	18	18	4	6	6
Overall Study NOT COMPLETED	1	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohorts 1 and 2: Placebo SC Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Overall Study Withdrawal by Subject	1	0	0	0	0	0

Baseline Characteristics

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohorts 1 and 2: Placebo SC n=13 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=18 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=4 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants n=6 Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants n=6 Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.	Total n=65 Participants Total of all reporting groups
Age, Customized 18-64 years	13 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	65 Participants n=8 Participants
Age, Customized >=65-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized >=85 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=8 Participants	33 Participants n=8 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants	32 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	11 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized White: White/Caucasian/European Heritage	8 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	35 Participants n=8 Participants
Race/Ethnicity, Customized Asian: Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian: East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Asian: Japanese Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	0 Participants n=8 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Asian: South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to Day 85

Population: Safety Population consisted of all randomized participants who took at least 1 dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment.

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=13 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=18 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=4 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants n=6 Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants n=6 Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	3 Participants	2 Participants	3 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847. Pharmacokinetic Population consisted of all randomized participants who received at least one dose of study treatment, and for whom at least one pharmacokinetic sample was obtained, analyzed and measurable.

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=18 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=6 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=6 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Area Under the Plasma Concentration Time Curve From 0 to t (AUC[0-t]) of GSK3772847	4139.092 Hours*microgram per milliliter Geometric Coefficient of Variation 34.1	10271.279 Hours*microgram per milliliter Geometric Coefficient of Variation 25.2	13356.462 Hours*microgram per milliliter Geometric Coefficient of Variation 29.7	11285.792 Hours*microgram per milliliter Geometric Coefficient of Variation 25.4	—	—

PRIMARY outcome

Timeframe: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=18 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=6 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=6 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3772847	4336.865 Hours*microgram per milliliter Geometric Coefficient of Variation 32.9	10575.235 Hours*microgram per milliliter Geometric Coefficient of Variation 25.2	13936.982 Hours*microgram per milliliter Geometric Coefficient of Variation 34.0	11576.445 Hours*microgram per milliliter Geometric Coefficient of Variation 26.6	—	—

PRIMARY outcome

Timeframe: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=18 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=6 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=6 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Maximum Observed Plasma Concentration (Cmax) of GSK3772847	7.8276 Microgram per milliliter Geometric Coefficient of Variation 38.4	15.0569 Microgram per milliliter Geometric Coefficient of Variation 24.5	15.9309 Microgram per milliliter Geometric Coefficient of Variation 25.5	15.8324 Microgram per milliliter Geometric Coefficient of Variation 15.2	—	—

PRIMARY outcome

Timeframe: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=18 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=6 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=6 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Time to Cmax (Tmax) of GSK3772847	120.000 Hours Interval 48.0 to 382.42	130.358 Hours Interval 71.95 to 311.8	146.175 Hours Interval 144.93 to 312.63	204.925 Hours Interval 72.0 to 381.65	—	—

PRIMARY outcome

Timeframe: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=18 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=6 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=6 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Apparent Terminal Half-life (t1/2) of GSK3772847	243.275 Hours Geometric Coefficient of Variation 17.1	293.144 Hours Geometric Coefficient of Variation 27.6	342.622 Hours Geometric Coefficient of Variation 36.8	291.690 Hours Geometric Coefficient of Variation 22.2	—	—

SECONDARY outcome

Timeframe: Baseline and up to Day 85/early withdrawal

Population: Pharmacodynamic Population. Only those participants with data available at indicated time points were analyzed.

Blood samples were collected to measure free soluble ST2 concentration. Maximal decrease from Baseline was the largest decrease calculated across all time points post dose. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was the most recent recorded value before dosing on Day 1 (Pre-dose). Pharmacodynamic Population consisted of all randomized participants who received at least one dose of study treatment, and for whom at least one pharmacokinetic sample was obtained, analyzed and measurable.

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=11 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=18 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=4 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants n=6 Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants n=6 Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Maximal Decrease in Ratio to Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration	0.7573 Ratio Interval 0.6586 to 0.966	0.0621 Ratio Interval 0.0512 to 0.0871	0.0417 Ratio Interval 0.0372 to 0.0511	0.8073 Ratio Interval 0.715 to 0.9028	0.0453 Ratio Interval 0.0311 to 0.0638	0.0433 Ratio Interval 0.0399 to 0.0469

SECONDARY outcome

Timeframe: Baseline and up to Day 85/early withdrawal

Population: Pharmacodynamic Population. Only those participants with data available at indicated time points were analyzed.

Blood samples were collected to measure total soluble ST2 concentration. Maximal increase from Baseline was the largest increase calculated across all timepoints post dose. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was the most recent recorded value before dosing on Day 1 (Pre-dose).

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=12 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=18 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=4 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants n=6 Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants n=6 Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Maximal Increase in Ratio to Baseline in Total Soluble ST2 Concentration	2.0573 Ratio Interval -1.8417 to 10.8808	25.4604 Ratio Interval 22.1566 to 31.4077	40.6790 Ratio Interval 9.4889 to 112.208	1.7203 Ratio Interval 1.1951 to 2.2921	39.1039 Ratio Interval 29.7883 to 50.6161	45.7791 Ratio Interval 35.8528 to 57.6231

SECONDARY outcome

Timeframe: Days 1, 15, 29, 57 and 85/early withdrawal

Population: Pharmacodynamic Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in the category titles).

Serum samples were collected at indicated time points and analyzed for the presence of anti-GSK3772847 antibodies using a tiered approach including a screening assay, a confirmation assay and calculation of titer.

Outcome measures

Outcome measures
Measure	Cohorts 1 and 2: Placebo SC n=13 Participants Participants received a single dose of placebo subcutaneous (SC) injection in the upper arm, abdomen or thigh by a health care professional in Cohorts 1 and 2.	Cohort 1: GSK3772847 70 mg SC n=18 Participants Participants received a single dose of GSK3772847 70 milligram (mg) SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 1.	Cohort 2: GSK3772847 140 mg SC n=18 Participants Participants received a single dose of GSK3772847 140 mg SC injection in the upper arm, abdomen or thigh by a health care professional in Cohort 2.	Cohorts 3 and 4: Placebo SC n=4 Participants Japanese and Chinese participants received a single dose of placebo SC injection in the upper arm by a health care professional in Cohorts 3 and 4.	Cohort 3: GSK3772847 140 mg SC in Japanese Participants n=6 Participants Japanese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 3.	Cohort 4: GSK3772847 140 mg SC in Chinese Participants n=6 Participants Chinese participants received a single dose of GSK3772847 140 mg SC injection in the upper arm by a health care professional in Cohort 4.
Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies Day 1: n=13,18,18,4,6,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies Day 15: n=13,18,18,4,6,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies Day 29: n=12,18,17,4,6,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies Day 57: n=12,18,18,4,6,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies Day 85/early withdrawal: n=12,18,18,4,6,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Days 5, 15, 29 and 85/early withdrawal

Population: Pharmacodynamic Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in the category titles).

Blood samples were collected at indicated time points to measure 4BetaOH cholesterol/cholesterol. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline value was the latest pre-dose assessment (Day 1 Pre-dose).