Study of GSK3511294 in Healthy Chinese Participants

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Biological: GSK3511294

Study type

Interventional

Funder types

Industry

Identifiers

NCT05140200

208021

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.