| Primary | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population comprised of all participants who received at least one dose of the study treatment (including placebo). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| | | Title | Denominators | Categories |
|---|
| DBP, Day 1: 1 hour, n=3,3,6 | - ParticipantsOG0003
- ParticipantsOG0013
- ParticipantsOG0026
| |
| |
| Primary | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 169-Interim Analysis) | SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | mmHg | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | |
|
| Primary | Part 2: Change From Baseline in SBP and DBP at Indicated Time Points (Up to Day 450-Optional Follow-up) | SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | mmHg | | Baseline (Day 1 pre-dose), Day 270 and Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Change From Baseline in Heart Rate at Indicated Time Points | Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | |
|
| Primary | Part 2: Change From Baseline in Heart Rate at Indicated Time Points (Up to Day 450-Optional Follow-up) | Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1 pre-dose), Day 270 and Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points | Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (Day 1 pre-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 169-Interim Analysis) | Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | |
|
| Primary | Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points (Up to Day 450-Optional Follow-up) | Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (Day 1 pre-dose), Day 270 and Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Change From Baseline in Body Temperature at Indicated Time Points | Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Degrees Celsius | | Baseline (Day 1 pre-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 169-Interim Analysis) | Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Degrees Celsius | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | |
|
| Primary | Part 2: Change From Baseline in Body Temperature at Indicated Time Points (Up to Day 450-Optional Follow-up) | Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Degrees Celsius | | Baseline (Day 1 pre-dose), Day 270 and Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Number of Participants With Abnormal Findings in Physical Examination | Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database. | Safety Population. Data was not collected and not captured in the database. | Posted | | | | | | Up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Number of Participants With Abnormal Findings in Physical Examination (Up to Day 169-Interim Analysis) | Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database. | Safety Population. Data was not collected and not captured in the database. | Posted | | | | | | Up to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG003 |
|
| Primary | Part 2: Number of Participants With Abnormal Findings in Physical Examination (Up to Day 450-Optional Follow-up) | Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. Data was not collected and not captured in the database. | Safety Population. Data was not collected and not captured in the database. | Posted | | | | | | Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG003 |
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| Primary | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters | Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, Activated partial thromboplastin time (aPTT), Prothrombin international normalized ratio (INR) and Prothrombin time (PT). Laboratory parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. | | Posted | | Count of Participants | | Participants | | Up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg |
|
| Primary | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 169-Interim Analysis) | Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. | | Posted | | Count of Participants | | Participants | | Up to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 |
|
| Primary | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters (Up to Day 450-Optional Follow-up) | Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. | | Posted | | Count of Participants | | Participants | | Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 |
|
| Primary | Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points | Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Milligram per deciliter | | Baseline (Day 1 pre-dose) and Up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Milligram per deciliter | | Baseline (Day 1 pre-dose) and Up to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
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| Primary | Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | Blood samples were planned to be collected from participants to evaluate change from Baseline in complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Data was not collected for this outcome measure during optional follow-up period. | Posted | | | | | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Change From Baseline in Complement Bb Level at Indicated Time Points | Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Milligram per liter | | Baseline (Day 1 pre-dose) and Up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Milligram per liter | | Baseline (Day 1 pre-dose) and Up to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | Blood samples were collected from participants to evaluate change from Baseline in complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Milligram per liter | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Change From Baseline in Complement C5a Level at Indicated Time Points | Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Microgram per liter | | Baseline (Day 1 pre-dose) and Up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 169-Interim Analysis) | Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Microgram per liter | | Baseline (Day 1 pre-dose) and Up to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points (Up to Day 450-Optional Follow-up) | Blood samples were collected from participants to evaluate change from Baseline in complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Milligrams per liter | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters | Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low) and Urate. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. | | Posted | | Count of Participants | | Participants | | Up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg |
|
| Primary | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 169-Interim Analysis) | Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. | | Posted | | Count of Participants | | Participants | | Up to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters (Up to Day 450-Optional Follow-up) | Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented. | | Posted | | Count of Participants | | Participants | | Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Change From Baseline in Urine Albumin at Indicated Time Points | Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Milligram per deciliter | | Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 169-Interim Analysis) | Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Milligram per deciliter | | Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 2: Change From Baseline in Urine Albumin at Indicated Time Points (Up to Day 450-Optional Follow-up) | Urine samples were planned to be collected from participants to evaluate change from Baseline in urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Data was not collected for this outcome measure during optional follow-up period. | Posted | | | | | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points | Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 169-Interim Analysis) | Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points (Up to Day 450-Optional Follow-up) | Urine samples were planned to be collected from participants to evaluate change from Baseline in urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Data was not collected for this outcome measure during optional follow-up period. | Posted | | | | | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points | Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | pH | | Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 169-Interim Analysis) | Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | pH | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly |
|
| Primary | Part 2: Change From Baseline in Urine pH at Indicated Time Points (Up to Day 450-Optional Follow-up) | Urine samples were planned to be collected from participants to evaluate change from Baseline in urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Data was not collected for this outcome measure during optional follow-up period. | Posted | | | | | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | |
|
| Primary | Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points | Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Ratio | | Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 169-Interim Analysis) | Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Ratio | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 |
|
| Primary | Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points (Up to Day 450-Optional Follow-up) | Urine samples were planned to be collected from participants to evaluate change from Baseline in urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Data was not collected for this outcome measure during optional follow-up period. | Posted | | | | | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | |
|
| Primary | Part 1: Change From Baseline in Urobilinogen at Indicated Time Points | Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | | Posted | | Mean | Standard Deviation | Milligram per deciliter | | Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60) | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 169-Interim Analysis) | Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Milligram per deciliter | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | |
|
| Primary | Part 2: Change From Baseline in Urobilinogen at Indicated Time Points (Up to Day 450-Optional Follow-up) | Urine samples were planned to be collected from participants to evaluate change from Baseline in urobilinogen. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was to be calculated by subtracting Baseline value from the post-dose visit value. | Safety Population. Data was not collected for this outcome measure during optional follow-up period. | Posted | | | | | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Electrocardiograms were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Count of Participants | | Participants | | Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
|
| Primary | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 169-Interim Analysis) | Electrocardiogram were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals. CS and NCS abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. | Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Count of Participants | | Participants | | Days 29, 57, 85 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 2: Number of Participants With Abnormal ECG Findings (Up to Day 450-Optional Follow-up) | ECGs were planned to be obtained after 5 minutes of rest in the semi-supine or supine position using ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTcF intervals. | Safety Population. Data was not collected for this outcome measure during optional follow-up period. | Posted | | | | | | Days 270, 360 and 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | |
|
| Primary | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a 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 or any other situation according to medical or scientific judgment were categorized as SAE. | | Posted | | Count of Participants | | Participants | | Up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Number of Participants With AEs and SAEs (Up to Day 169-Interim Analysis) | An AE is any untoward medical occurrence in a 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 or any other situation according to medical or scientific judgment were categorized as SAE. | | Posted | | Count of Participants | | Participants | | Up to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 2: Number of Participants With AEs and SAEs (Up to Day 450-Optional Follow-up) | An AE is any untoward medical occurrence in a 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 or any other situation according to medical or scientific judgment were categorized as SAE. | | Posted | | Count of Participants | | Participants | | Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for GSK3389404 | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population comprised of all participants in the Safety population for whom at least one evaluable pharmacokinetic sample were obtained and analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: AUC (0-t) for GSK3389404 | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for GSK3389404 | Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: AUC (0-infinity) for GSK3389404 | Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3389404 | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Cmax of GSK3389404 | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Time to Achieve Cmax (Tmax) of GSK3389404 | Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population | Posted | | Median | Full Range | Hours | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Tmax of GSK3389404 | Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Median | Full Range | Hours | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Apparent Terminal Phase Half-life(t1/2) of GSK3389404 | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: t1/2 of GSK3389404 | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Apparent Subcutaneous Plasma Clearance (CL/F) of GSK3389404 | Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | 95% Confidence Interval | Liters per hour | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: CL/F of GSK3389404 | Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | 95% Confidence Interval | Liters per hour | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Primary | Part 1: Number of Participants Achieving Response Rate (RR) Based on Reduction of Hepatitis B Surface Antigen (HBsAg) Level From Baseline | The RR was based on the proportion of participants with at least a 1.5 logarithm to the base 10 (log10) international units per milliliter (IU/mL) reduction of HBsAg levels from Baseline at any time up to Day 60. Number of participants who achieved >1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 60 are presented. | Intent-To-Treat (ITT) Population comprised of all randomized participants. | Posted | | Count of Participants | | Participants | | Up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Primary | Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline | The RR was based on the proportion of participants with at least a 1.5 log10 IU/mL reduction of HBsAg levels from Baseline at any time up to Day 85. Number of participants who achieved >1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 85 are presented. | ITT Population. Data is presented only for interim analysis; since this analysis was not planned for optional follow-up period (up to Day 450). | Posted | | Count of Participants | | Participants | | Up to Day 85 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points | Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | Pharmacodynamic Population comprised of all participants in the Safety Population who provided evaluable pharmacodynamic data. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose), Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
|
| Secondary | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose) and Up to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose) and Up to Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points | Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | Pharmacodynamic Population | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Secondary | Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 2: Change From Baseline in log10 HBsAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Blood samples were collected from participants to assess HBsAg level. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose), Day 270, Day 360 and Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points | Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: Placebo | Participants received a single dose of Placebo via subcutaneous (SC) route on Day 1. | | OG001 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG002 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Secondary | Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points (Up to Day 169-Interim Analysis) | Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 2: Change From Baseline in log10 HBeAg Level in Plasma at Indicated Time Points (Up to Day 450-Optional Follow-up) | Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline). | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1 pre-dose), Day 270, Day 360 and Day 450 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: Placebo | Participants received once weekly SC dose of Placebo until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 1: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Secondary | Part 2: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358) | Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 1: Cmax of GSK3389404 Metabolite (ISIS 505358) | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Secondary | Part 2: Cmax of GSK3389404 Metabolite (ISIS 505358) | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
|
| Secondary | Part 1: Tmax of GSK3389404 Metabolite (ISIS 505358) | Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Median | Full Range | Hours | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
| |
| Secondary | Part 2: Tmax of GSK3389404 Metabolite (ISIS 505358) | Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Median | Full Range | Hours | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
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| Secondary | Part 1: t1/2 of GSK3389404 Metabolite (ISIS 505358) | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30 | | | | ID | Title | Description |
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| OG000 | Part 1: GSK3389404 30 mg | Participants received a single dose of GSK3389404 30 mg via SC route on Day 1. | | OG001 | Part 1: GSK3389404 120 mg | Participants received a single dose of GSK3389404 120 mg via SC route on Day 1. |
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| Secondary | Part 2: t1/2 of GSK3389404 Metabolite (ISIS 505358) | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169 | | | | ID | Title | Description |
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| OG000 | Part 2: GSK3389404 30 mg Weekly | Participants received once weekly SC dose of GSK3389404 30 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG001 | Part 2: GSK3389404 60 mg Weekly | Participants received once weekly SC dose of GSK3389404 60 mg until Day 78. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. | | OG002 | Part 2: GSK3389404 120 mg Bi-weekly | Participants received bi-weekly SC dose of GSK3389404 120 mg until Day 71. Participants who completed Day 169 visit were given an option to enter optional follow-up (FU) period up to Day 450. |
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