Study of GSK3511294 in Healthy Chinese Participants

NCT ID: NCT05140200

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-12-23

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study.

Study Groups

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Cohort 1: Participants receiving GSK3511294 at Dose level 1

Group Type EXPERIMENTAL

GSK3511294

Intervention Type BIOLOGICAL

GSK3511294 will be administered.

Cohort 2: Participants receiving GSK3511294 at Dose level 2

Group Type EXPERIMENTAL

GSK3511294

Intervention Type BIOLOGICAL

GSK3511294 will be administered.

Interventions

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GSK3511294

GSK3511294 will be administered.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hangzhou, , China

Site Status

Countries

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China

Other Identifiers

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208021

Identifier Type: -

Identifier Source: org_study_id

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