Study of GSK3511294 in Healthy Chinese Participants

NCT05140200 | Completed Phase 1 Results

• 1 other identifier: 208021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Single dose study; Immunogenicity; GSK3511294; Chinese healthy participants

Outcome Measures

Primary Outcomes (13)

• 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.

  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

Secondary Outcomes (20)

• Number of Participants With Adverse Events (AE) And Serious Adverse Events (SAEs)

  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

  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

  Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26

• Change From Baseline in Hematology Parameter: Hematocrit

  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)

  Baseline (Day -1), Days 2, 3, 5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26

Study Arms (2)

Depemokimab 100mg

EXPERIMENTAL

Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.

Biological: Depemokimab

Depemokimab 300mg

EXPERIMENTAL

Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.

Biological: Depemokimab

Interventions

Depemokimab BIOLOGICAL

Depemokimab was administered.

Also known as: GSK3511294

Depemokimab 100mg; Depemokimab 300mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant between 18 to 45 years of age.
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiograms and vital signs.
• Body weight greater than or equal to (\>=)50.0 kilograms (kg) for males, \>=45.0 kg for females, and body mass index (BMI) within the range (19.0-26.0) kg/meter square (m\^2) (inclusive).
• Contraceptive use by men and/or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent.

You may not qualify if:

• Participant is pregnant, breastfeeding, or a woman of childbearing potential
• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe allergic reactions/intolerance
• Current evidence or recent history of an infective illness
• A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
• Clinically significant abnormalities
• Participants with Coronavirus Disease-2019 (COVID-19)
• With prior/concurrent clinical study experience.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hangzhou, 310006, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 1, 2021
• Study Start: December 10, 2021
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: May 26, 2026
• Results First Posted: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

CN (1)