Recruiting
Sponsor ID
20240037

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

Sponsor ID
20240037
Clinicaltrials.gov ID
NCT07745907
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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

Additional Study Details

Phase
Phase 1
Product
AMG 691
Type
Interventional
Masking
None (Open Label)
Enrollment
28
Additional Study Details

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
Status
Contact Us
Location
PPD - Las Vegas Research Unit
Las Vegas, Nevada, United States, 89113
Status
Recruiting