Study of GSK3511294 in Healthy Chinese Participants

NCT05140200 | Completed Phase 1

• 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 GSK3511294

  Up to Week 26

• AUC from time 0 (pre-dose) to last time of quantifiable concentration within a participant across all treatments (AUC[0-t]) of GSK3511294

  Up to Week 26

• AUC from time 0 to Week 4 (AUC[0-Week 4]) of GSK3511294

  Up to Week 4

• AUC from time 0 to Week 12 (AUC[0-Week 12]) of GSK3511294

  Up to Week 12

• AUC from Time 0 to Week 26 [AUC(0-Week 26)] of GSK3511294

  Up to Week 26

• Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of GSK3511294

  Up to Week 26

• Maximum observed plasma concentration (Cmax) of GSK3511294

  Up to Week 26

• Time of occurrence of Cmax (tmax) of GSK3511294

  Up to Week 26

• Time to last quantifiable concentration (tlast) of GSK3511294

  Up to Week 26

• Apparent clearance (CL/F) of GSK3511294

  Up to Week 26

• Apparent volume of distribution (Vz/F) of GSK3511294

  Up to Week 26

• Terminal elimination rate constant (lambda z) of GSK3511294

  Up to Week 26

• Terminal phase half-life (t1/2) of GSK3511294

  Up to Week 26

Secondary Outcomes (20)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  Up to Week 30

• Change from Baseline in platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes and neutrophils (10^9 cells per liter)

  Baseline (Pre-dose on Day 1) and up to Week 26

• Change from Baseline in Red blood cell (RBC) count (10^12 cells per liter)

  Baseline (Pre-dose on Day 1) and up to Week 26

• Change from Baseline in Hemoglobin (Grams per liter)

  Baseline (Pre-dose on Day 1) and up to Week 26

• Change from Baseline in hematocrit (Proportion of RBC in blood)

  Baseline (Pre-dose on Day 1) and up to Week 26

Study Arms (2)

Cohort 1: Participants receiving GSK3511294 at Dose level 1

EXPERIMENTAL

Biological: GSK3511294

Cohort 2: Participants receiving GSK3511294 at Dose level 2

EXPERIMENTAL

Biological: GSK3511294

Interventions

GSK3511294 BIOLOGICAL

GSK3511294 will be administered.

Cohort 1: Participants receiving GSK3511294 at Dose level 1; Cohort 2: Participants receiving GSK3511294 at Dose level 2

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

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: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.

Locations

CN (1)