Recruiting
Sponsor ID
20240037
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Study Details
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants
Protocol Summary
Primary Outcome Measures
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 Outcome Measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 to end of trial (approximately 154 days)
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: From screening (Day -28) up to end of trial (approximately 154 days)
Number of Participants Who Develop Anti-AMG 691 Antibodies
Timeframe: Up to Day 154
Locations
Location
PPD - Las Vegas Research Unit
Las Vegas, Nevada, United States, 89113
Status
Recruiting