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NCT07745907

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

StatusActive, Not Recruiting
PhasePhase 1
SponsorAmgen
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 3 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Primary and study completion dates: Mar 31, 2027 to Mar 17, 2027
    • Site details revised
  2. Eligibility criteria expanded, about 24 words
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Maximum Observed Serum Concentration (Cmax) of AMG 691
Timeframe: Day 1 up to Day 154
Area Under the Serum Concentration Time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of AMG 691
Timeframe: Up to Day 154
Area Under the Serum concentration Time Curve from Time Zero to Infinity (AUC0-inf) of AMG 691
Timeframe: Up to Day 154

Secondary (3)

Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants Who Develop Anti-AMG 691 Antibodies

Arms and interventions

Cohort 1Experimental

Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC)

Cohort 2Experimental

Japanese participants will receive AMG 691 at the Level A dose administered SC

Cohort 3Experimental

Chinese participants will receive AMG 691 at the Level B dose administered SC

Cohort 4Experimental

Japanese participants will receive AMG 691 at the Level B dose administered SC

Drugs: AMG 691

Sites

1 site in 1 country

  • PPD - Las Vegas Research UnitLas Vegas, Nevada, United States