Study of GSK3511294 in Healthy Chinese Participants

Sponsor
GlaxoSmithKline
Study ID
NCT05140200
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Depemokimab — BIOLOGICAL
    Depemokimab was administered.

Study Details

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

Key Dates

Start date
Dec 10, 2021
Status verified
May 2026
Primary completion
Dec 23, 2022
Completion
Dec 23, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Depemokimab 100mg
    Healthy Chinese participants received a single dose of 100 mg Depemokimab subcutaneously on Day 1.
  • Experimental: Depemokimab 300mg
    Healthy Chinese participants received a single dose of 300 mg Depemokimab subcutaneously on Day 1.

Primary Outcome Measure

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero (Pre-Dose) Extrapolated to Infinite Time (AUC[0-Infinity]) of Depemokimab [ Time Frame: 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 ]

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