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Study of GSK3511294 in Healthy Chinese Participants
Study of GSK3511294 in Healthy Chinese Participants

NCT05140200

CompletedPhase 1

Sponsor: GlaxoSmithKline

Conditions: Asthma

Interventions: Depemokimab

Countries: China

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

Eligibility overview

Sex: ALL

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Hangzhou, China