A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Amgen
Study ID
NCT07745907
Phase
PHASE1
Status
Recruiting

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • AMG 691 — DRUG
    AMG 691 will be administered subcutaneously

Study Details

The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants

Key Dates

First listed
Aug 4, 2026
Start date
Aug 7, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1
    Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC)
  • Experimental: Cohort 2
    Japanese participants will receive AMG 691 at the Level A dose administered SC
  • Experimental: Cohort 3
    Chinese participants will receive AMG 691 at the Level B dose administered SC
  • Experimental: Cohort 4
    Japanese participants will receive AMG 691 at the Level B dose administered SC

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) of AMG 691 [ Time Frame: Day 1 up to Day 154 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PPD - Las Vegas Research UnitLas VegasNevada89113-

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