A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants

Part of paid clinical trials in Orlando, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT05602025
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Depemokimab — BIOLOGICAL
    Depemokimab was administered via SSD or autoinjector.

Study Details

This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.

Key Dates

Start date
Dec 13, 2022
Status verified
May 2026
Primary completion
Oct 23, 2023
Completion
Oct 23, 2023

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Depemokimab via SSD
    Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
  • Experimental: Depemokimab via autoinjector
    Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Depemokimab [ Time Frame: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose ]

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteOrlandoFlorida32806-
GSK Investigational SiteLas VegasNevada89113-
GSK Investigational SiteAustinTexas78744-

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