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This single dose pharmacokinetic (PK) study aims to investigate the PK, safety, tolerability and immunogenicity of two dose levels of GSK3511294 administered subcutaneously in Chinese healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depemokimab 100mg | Experimental | Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1. |
|
| Depemokimab 300mg | Experimental | Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depemokimab | Biological | Depemokimab was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Infinity). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183 |
| AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-T). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183 |
| AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 4). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 4 post-dose correlates to Day 1 plus 28 days, that is, Day 29. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29 |
| AUC From Time 0 (Pre-dose) To Week 12 (AUC[0-Week 12]) Of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 12). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, that is, Day 85. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is considered or defined as an important medical event. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hangzhou | 310006 | China |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
A total of 20 participants were enrolled and randomized in 1:1 ratio in each arm to receive either depemokimab 100 milligrams (mg) or 300 mg.
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| ID | Title | Description |
|---|---|---|
| FG000 | Depemokimab 100mg | Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1. |
| FG001 | Depemokimab 300mg | Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Depemokimab 100mg | Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1. |
| BG001 | Depemokimab 300mg | Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Infinity). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | day*micrograms per millilitres | Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183 |
|
All-cause mortality, Serious Adverse events (SAE) and non-SAEs were collected from the start of the study intervention (Day 1) up to Day 211 (End of follow-up).
The analysis was performed on Safety Analysis Set which was defined as all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Depemokimab 100mg | Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2021 | Apr 10, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2023 | Apr 10, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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This is an open-label study.
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| Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85 |
| AUC From Time 0 (Pre-dose) To Week 26 [AUC(0-Week 26)] of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 26). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for percentage of AUC(0-Infinity) obtained by extrapolation. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| Maximum Observed Plasma Concentration (Cmax) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| Time of Occurrence of Cmax (Tmax) Of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters were calculated by standard non compartmental analysis. Tmax was determined directly from the plasma concentration-time data. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| Time To Last Quantifiable Concentration (Tlast) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| Apparent Clearance (CL/F) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Apparent Clearance. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| Apparent Volume of Distribution (Vz/F) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for apparent volume of distribution. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| Terminal Elimination Rate Constant (Lambda Z) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Terminal elimination rate constant. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| Terminal Phase Half-Life (T1/2) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Terminal phase half-life. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
| From the start of the study intervention (Day 1) up to Day 211 (End of follow-up) |
| Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes | Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential that is, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26 |
| Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected for the assessment of change from baseline in hematology parameters including Hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
| Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected for the assessment of change from baseline in hematology parameters including Hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
| Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Blood samples were collected for the assessment of change from baseline in hematology parameters including mean corpuscular volume. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
| Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Blood samples were collected for the assessment of change from baseline in hematology parameters including mean Corpuscular Hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
| Change From Baseline in Hematology Parameter: Reticulocytes | Blood samples were collected for the assessment of change from baseline in hematology parameters including Reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26 |
| Change From Baseline In Hematology Parameter: Erythrocytes | Change from baseline in hematology parameter including Erythrocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26 |
| Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea | Blood samples was collected for the assessment of clinical chemistry parameters including Sodium, potassium, calcium, glucose, and urea. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Pre-dose on Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
| Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine | Blood samples was collected for the assessment of clinical chemistry parameters including direct bilirubin, bilirubin, and creatinine[MB10.1]. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
| Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) | Blood samples was collected for the assessment of clinical chemistry parameters including AST, ALT, ALP, and GGT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
| Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein | Blood samples was collected for the assessment of clinical chemistry parameters including Albumin. and Total Protein. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
| Absolute Values of Complement C3 And C4 at Each Timepoint | Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value. | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
| Ratio to Baseline at Each Timepoint of Complement C3 And C4 | Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value. | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
| Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic blood pressure (sBP) is a measure of blood pressure while the heart is beating. Diastolic blood pressure (dBP) is a measure of blood pressure while the heart is relaxed. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
| Change From Baseline in Body Temperature | Body temperature was measured in participants in resting state. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Day 2, 3, 5, Week 1, 2, 4, 8, 12, 18, 24 and 26 |
| Change From Baseline in Pulse Rate | The vital signs followed in this analysis was pulse rate, expressed as beats per minute (bpm). Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26 |
| Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate | 12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR interval, QRS duration, QT interval and corrected QT using Fridericia's Formula (QTc[MB13.1]F) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the aggregate [MB14.1]value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26 |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab | Serum samples were collected to determine the presence of anti-depemokimab binding antibodies using a validated bioanalytical method. Data is reported by visit. The results were categorized as negative and positive. A participant is considered positive if they have at least one positive post-Baseline ADA result. Number of participants with positive ADAs against depemokimab was reported in this outcome measure. | Day 1 (Pre-dose), Week 4, Week 12, and Week 26 |
| Titres of Binding ADA's to Depemokimab | Serum samples were collected to determine the presence of anti-depemokimab binding antibodies using a validated bioanalytical method. Data is reported by visit. Titer was only measured when a positive result was found. | Up to Week 26 |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| OG000 |
| Depemokimab 100mg |
Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1. |
| OG001 | Depemokimab 300mg | Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1. |
|
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| Primary | AUC From Time 0 (Pre-Dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-T]) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-T). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | day*micrograms per millilitres | Day 1 (Pre-dose, 2h, and 8h Post-dose), Day 2, Day 3, Day 5, Day 8, Day 15, Day 29, Day 57, Day 85, Day 127, Day 169, and Day 183 |
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| Primary | AUC From Time 0 (Pre-dose) to Week 4 (AUC[0-Week 4]) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 4). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 4 post-dose correlates to Day 1 plus 28 days, that is, Day 29. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | day*micrograms per millilitres | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, and 29 |
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| Primary | AUC From Time 0 (Pre-dose) To Week 12 (AUC[0-Week 12]) Of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 12). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 12 post-dose correlates to Day 1 plus 84 days, that is, Day 85. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | day*micrograms per millilitres | Pre-dose (Day 1); 2 h, 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, and 85 |
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| Primary | AUC From Time 0 (Pre-dose) To Week 26 [AUC(0-Week 26)] of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for AUC(0-Week 26). Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | day*micrograms per millilitres | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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| Primary | Percentage Of AUC(0-Infinity) Obtained by Extrapolation (%AUCex) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for percentage of AUC(0-Infinity) obtained by extrapolation. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Percentage of AUCex | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. | Posted | Geometric Mean | 95% Confidence Interval | micrograms per milliliters (mcg/mL) | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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| Primary | Time of Occurrence of Cmax (Tmax) Of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters were calculated by standard non compartmental analysis. Tmax was determined directly from the plasma concentration-time data. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. | Posted | Median | Full Range | Days | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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| Primary | Time To Last Quantifiable Concentration (Tlast) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Median | Full Range | Days | Pre-dose (day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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| Primary | Apparent Clearance (CL/F) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Apparent Clearance. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Liters per day | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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| Primary | Apparent Volume of Distribution (Vz/F) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for apparent volume of distribution. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Litres | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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|
| Primary | Terminal Elimination Rate Constant (Lambda Z) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Terminal elimination rate constant. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Per Day | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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|
| Primary | Terminal Phase Half-Life (T1/2) of Depemokimab | Blood samples were collected from participants at indicated time points and analyzed for Terminal phase half-life. Pharmacokinetic parameters were calculated by standard non compartmental analysis. As the first dose of depemokimab was administered on Day 1, Week 26 post-dose correlates to Day 1 plus 182 days, that is, Day 183. | The analysis was performed on pharmacokinetic set which included all participants who received at least one dose of study intervention and for whom at least one evaluable pharmacokinetic sample was obtained and analysed. Participants were analyzed according to the intervention they actually received. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Days | Pre-dose (Day 1); 2 hours (h), 8 h, 24 h, and 48 h post-dose; Days 5, 8, 15, 29, 57, 85, 127, 169, and 183 |
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| Secondary | Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is considered or defined as an important medical event. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. | Posted | Count of Participants | Participants | From the start of the study intervention (Day 1) up to Day 211 (End of follow-up) |
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| Secondary | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes | Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential that is, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26 |
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| Secondary | Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected for the assessment of change from baseline in hematology parameters including Hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Gram per Liter | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
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| Secondary | Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected for the assessment of change from baseline in hematology parameters including Hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Liter/liter | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
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| Secondary | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Blood samples were collected for the assessment of change from baseline in hematology parameters including mean corpuscular volume. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Femtoliters | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
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| Secondary | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Blood samples were collected for the assessment of change from baseline in hematology parameters including mean Corpuscular Hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Picograms (pg) | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
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| Secondary | Change From Baseline in Hematology Parameter: Reticulocytes | Blood samples were collected for the assessment of change from baseline in hematology parameters including Reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Percentage | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26 |
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| Secondary | Change From Baseline In Hematology Parameter: Erythrocytes | Change from baseline in hematology parameter including Erythrocytes. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | 10^12 cells per liter | Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and Week 26 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose And Urea | Blood samples was collected for the assessment of clinical chemistry parameters including Sodium, potassium, calcium, glucose, and urea. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Millimoles per liter | Baseline (Pre-dose on Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, and Creatinine | Blood samples was collected for the assessment of clinical chemistry parameters including direct bilirubin, bilirubin, and creatinine[MB10.1]. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Micromoles per Liter | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) | Blood samples was collected for the assessment of clinical chemistry parameters including AST, ALT, ALP, and GGT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Units Per Liter | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
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| Secondary | Change From Baseline In Clinical Chemistry Parameter of Albumin and Total Protein | Blood samples was collected for the assessment of clinical chemistry parameters including Albumin. and Total Protein. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Grams per Liter | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
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| Secondary | Absolute Values of Complement C3 And C4 at Each Timepoint | Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Geometric Mean | 95% Confidence Interval | Grams per Liter | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
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| Secondary | Ratio to Baseline at Each Timepoint of Complement C3 And C4 | Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day -1), Week 1, 4, 8, 12, 24 and Week 26 |
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| Secondary | Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic blood pressure (sBP) is a measure of blood pressure while the heart is beating. Diastolic blood pressure (dBP) is a measure of blood pressure while the heart is relaxed. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 |
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| Secondary | Change From Baseline in Body Temperature | Body temperature was measured in participants in resting state. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (Day -1), Day 1 (2 hours), Day 1 (8 hours), Day 2, 3, 5, Week 1, 2, 4, 8, 12, 18, 24 and 26 |
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| Secondary | Change From Baseline in Pulse Rate | The vital signs followed in this analysis was pulse rate, expressed as beats per minute (bpm). Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Beats per minute (BPM) | Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26 |
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| Secondary | Change From Baseline in ECG Parameters: PR Interval, Aggregate, QRS Duration, Aggregate, QT Interval, Aggregate, QTcF Interval, Aggregate | 12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR interval, QRS duration, QT interval and corrected QT using Fridericia's Formula (QTc[MB13.1]F) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the aggregate [MB14.1]value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Milliseconds | Baseline (Day -1), Day 1 (2 hour), Day 1 (8 hour), Day 2, 3, 5, Week 1, 4, 8, 12, 18, 24 and Week 26 |
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| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Depemokimab | Serum samples were collected to determine the presence of anti-depemokimab binding antibodies using a validated bioanalytical method. Data is reported by visit. The results were categorized as negative and positive. A participant is considered positive if they have at least one positive post-Baseline ADA result. Number of participants with positive ADAs against depemokimab was reported in this outcome measure. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Count of Participants | Participants | Day 1 (Pre-dose), Week 4, Week 12, and Week 26 |
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| Secondary | Titres of Binding ADA's to Depemokimab | Serum samples were collected to determine the presence of anti-depemokimab binding antibodies using a validated bioanalytical method. Data is reported by visit. Titer was only measured when a positive result was found. | The analysis was performed on the Safety Set that included all participants who received at least one dose of study intervention. Participants were analysed according to the intervention they actually received. No participants had positive ADAs to depemokimab therefore, no data was collected for titers of ADAs. | Posted | Up to Week 26 |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | Depemokimab 300mg | Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1. | 0 | 10 | 0 | 10 | 10 | 10 |
| Blood uric acid increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Albumin urine present | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Urinary casts present | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
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| Monocyte count increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Suspected COVID-19 | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
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| Skin injury | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
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| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v27.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Basophils, Day 3 |
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| Calcium, Week 26 |
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| Urea, Week 1 |
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| Urea, Week 4 |
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| Urea, Week 8 |
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| Urea, Week 12 |
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| Urea, Week 24 |
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| Urea, Week 26 |
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| Glucose, Week 1 |
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| Glucose, Week 4 |
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| Glucose, Week 8 |
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| Glucose, Week 12 |
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| Glucose, Week 24 |
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| Glucose, Week 26 |
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| Direct Bilirubin, Week 4 |
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| Direct Bilirubin, Week 8 |
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| Direct Bilirubin, Week 12 |
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| Direct Bilirubin, Week 24 |
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| Direct Bilirubin, Week 26 |
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| Bilirubin, Week 1 |
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| Bilirubin, Week 4 |
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| Bilirubin, Week 8 |
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| Bilirubin, Week 12 |
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| Bilirubin, Week 24 |
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| Bilirubin, Week 26 |
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| Creatinine, Week 1 |
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| Creatinine, Week 4 |
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| Creatinine, Week 8 |
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| Creatinine, Week 12 |
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| Creatinine, Week 24 |
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| Creatinine, Week 26 |
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| ALP, Week 4 |
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| ALP, Week 8 |
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| ALP, Week 12 |
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| ALP, Week 24 |
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| ALP, Week 26 |
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| ALT, Week 1 |
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| ALT, Week 4 |
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| ALT, Week 8 |
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| ALT, Week 12 |
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| ALT, Week 24 |
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| ALT, Week 26 |
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| AST, Week 1 |
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| AST, Week 4 |
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| AST, Week 8 |
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| AST, Week 12 |
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| AST, Week 24 |
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| AST, Week 26 |
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| GGT, Week 1 |
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| GGT, Week 4 |
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| GGT, Week 8 |
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| GGT, Week 12 |
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| GGT, Week 24 |
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| GGT, Week 26 |
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| Albumin, Week 4 |
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| Albumin, Week 8 |
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| Albumin, Week 12 |
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| Albumin, Week 24 |
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| Albumin, Week 26 |
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| Total Protein, Week 1 |
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| Total Protein, Week 4 |
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| Total Protein, Week 8 |
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| Total Protein, Week 12 |
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| Total Protein, Week 24 |
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| Total Protein, Week 26 |
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| Complement C3, Week 1 |
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| Complement C3, Week 4 |
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| Complement C3, Week 8 |
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| Complement C3, Week 12 |
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| Complement C3, Week 24 |
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| Complement C3, Week 26 |
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| Complement C4, Baseline |
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| Complement C4, Week 1 |
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| Complement C4, Week 4 |
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| Complement C4, Week 8 |
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| Complement C4, Week 12 |
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| Complement C4, Week 24 |
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| Complement C4, Week 26 |
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| Complement C3, Week 4, Ratio to Baseline |
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| Complement C3, Week 8, Ratio to Baseline |
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| Complement C3, Week 12, Ratio to Baseline |
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| Complement C3, Week 24, Ratio to Baseline |
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| Complement C3, Week 26, Ratio to Baseline |
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| Complement C4, Week 1, Ratio to Baseline |
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| Complement C4, Week 4, Ratio to Baseline |
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| Complement C4, Week 8, Ratio to Baseline |
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| Complement C4, Week 12, Ratio to Baseline |
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| Complement C4, Week 24, Ratio to Baseline |
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| Complement C4, Week 26, Ratio to Baseline |
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| sBP, Day 1 (8 hours) |
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| sBP, Day 2 |
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| sBP, Day 3 |
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| sBP, Day 5 |
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| sBP, Week 1 |
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| sBP, Week 2 |
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| sBP, Week 4 |
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| sBP, Week 8 |
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| sBP, Week 12 |
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| sBP, Week 18 |
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| sBP, Week 24 |
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| sBP, Week 26 |
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| dBP, Day 1 (2 hours) |
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| dBP, Day 1 (8 hours) |
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| dBP, Day 2 |
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| dBP, Day 3 |
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| dBP, Day 5 |
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| dBP, Week 1 |
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| dBP, Week 2 |
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| dBP, Week 4 |
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| dBP, Week 8 |
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| dBP, Week 12 |
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| dBP, Week 18 |
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| dBP, Week 24 |
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| dBP, Week 26 |
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| Day 1, 8 hours |
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| Day 2 |
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| Day 3 |
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| Day 5 |
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| Week 1 |
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| Week 2 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 18 |
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| Week 24 |
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| Week 26 |
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| Pulse Rate, Day 1, 8 hour |
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| Pulse Rate, Day 2 |
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| Pulse Rate, Day 3 |
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| Pulse Rate, Day 5 |
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| Pulse Rate, Week 1 |
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| Pulse Rate, Week 2 |
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| Pulse Rate, Week 4 |
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| Pulse Rate, Week 8 |
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| Pulse Rate, Week 12 |
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| Pulse Rate, Week 18 |
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| Pulse Rate, Week 24 |
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| Pulse Rate, Week 26 |
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|
| PR Interval, Aggregate, Day 1, 8 hour |
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| PR Interval, Aggregate, Day 2 |
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| PR Interval, Aggregate, Day 3 |
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| PR Interval, Aggregate, Day 5 |
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| PR Interval, Aggregate, Week 1 |
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| PR Interval, Aggregate, Week 2 |
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| PR Interval, Aggregate, Week 4 |
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| PR Interval, Aggregate, Week 8 |
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| PR Interval, Aggregate, Week 12 |
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| PR Interval, Aggregate, Week 18 |
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| PR Interval, Aggregate, Week 24 |
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| PR Interval, Aggregate, Week 26 |
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|
| QRS Duration, Aggregate, Day 1, 2 hour |
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| QRS Duration, Aggregate, Day 1, 8 hour |
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| QRS Duration, Aggregate, Day 2 |
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| QRS Duration, Aggregate, Day 3 |
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| QRS Duration, Aggregate, Day 5 |
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|
| QRS Duration, Aggregate, Week 1 |
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| QRS Duration, Aggregate, Week 2 |
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| QRS Duration, Aggregate, Week 4 |
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| QRS Duration, Aggregate, Week 8 |
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| QRS Duration, Aggregate, Week 12 |
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| QRS Duration, Aggregate, Week 18 |
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| QRS Duration, Aggregate, Week 24 |
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| QRS Duration, Aggregate, Week 26 |
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| QT Interval, Aggregate, Day 1, 2 hour |
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| QT Interval, Aggregate, Day 1, 8 hour |
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| QT Interval, Aggregate, Day 2 |
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| QT Interval, Aggregate, Day 3 |
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| QT Interval, Aggregate, Day 5 |
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| QT Interval, Aggregate, Week 1 |
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| QT Interval, Aggregate, Week 2 |
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|
| QT Interval, Aggregate, Week 4 |
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|
| QT Interval, Aggregate, Week 8 |
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| QT Interval, Aggregate, Week 12 |
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|
| QT Interval, Aggregate, Week 18 |
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| QT Interval, Aggregate, Week 24 |
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| QT Interval, Aggregate, Week 26 |
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|
| QTcF Interval, Aggregate, Day 1, 2 hour |
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| QTcF Interval, Aggregate, Day 1, 8 hour |
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| QTcF Interval, Aggregate, Day 2 |
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| QTcF Interval, Aggregate, Day 3 |
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| QTcF Interval, Aggregate, Day 5 |
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| QTcF Interval, Aggregate, Week 1 |
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| QTcF Interval, Aggregate, Week 2 |
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| QTcF Interval, Aggregate, Week 4 |
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| QTcF Interval, Aggregate, Week 8 |
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| QTcF Interval, Aggregate, Week 12 |
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| QTcF Interval, Aggregate, Week 18 |
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| QTcF Interval, Aggregate, Week 24 |
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| QTcF Interval, Aggregate, Week 26 |
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|
| Week 4 |
|
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| Week 12 |
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| Week 26 |
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