| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety Population consisted of all randomized participants who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | Up to Day 85 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. | | OG004 | 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. | | OG005 | 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. |
| | Units | Counts |
|---|
| Participants | - OG00013
- OG00118
- OG00218
- OG003
|
| | Title | Denominators | Categories |
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| AEs | | |
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| Primary | Area Under the Plasma Concentration Time Curve From 0 to t (AUC[0-t]) of GSK3772847 | 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. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3772847 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter | | Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Cohort 4: GSK3772847 140 mg SC in Chinese Participants |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of GSK3772847 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | | Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Cohort 4: GSK3772847 140 mg SC in Chinese Participants |
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| Primary | Time to Cmax (Tmax) of GSK3772847 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847. | Pharmacokinetic Population. | Posted | | Median | Full Range | Hours | | Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Cohort 4: GSK3772847 140 mg SC in Chinese Participants | |
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| Primary | Apparent Terminal Half-life (t1/2) of GSK3772847 | Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847. | Pharmacokinetic Population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Cohort 4: GSK3772847 140 mg SC in Chinese Participants |
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| Secondary | Maximal Decrease in Ratio to Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration | 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. | Pharmacodynamic Population. Only those participants with data available at indicated time points were analyzed. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline and up to Day 85/early withdrawal | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | Cohort 2: GSK3772847 140 mg SC |
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| Secondary | Maximal Increase in Ratio to Baseline in Total Soluble ST2 Concentration | 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). | Pharmacodynamic Population. Only those participants with data available at indicated time points were analyzed. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline and up to Day 85/early withdrawal | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies | 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. | Pharmacodynamic Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in the category titles). | Posted | | Count of Participants | | Participants | | Days 1, 15, 29, 57 and 85/early withdrawal | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Ratio to Baseline in Plasma 4 Beta-hydroxy (4BetaOH) Cholesterol/Cholesterol | 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). | Pharmacodynamic Population. Only those participants with data available at indicated time points were analyzed (represented by n=X in the category titles). | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline, Days 5, 15, 29 and 85/early withdrawal | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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