Study Complete
Sponsor ID
20140324
A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants
Study Details
The primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of AMG 592 in healthy participants.
Protocol Summary
Primary Outcome Measures
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 up to Day 57
Number of Participants with Anti-AMG 592 Antibodies
Timeframe: Day 1 up to Day 57
Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)
Timeframe: One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)
Timeframe: One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)
Timeframe: One week after AMG 592 administration (up to 7 days)
Secondary Outcome Measures
Maximum Observed Serum Concentration (Cmax) of AMG 592
Timeframe: Day 1 up to Day 57
Time of Maximum Observed Concentration (tmax) of AMG 592
Timeframe: Day 1 up to Day 57
Area Under the Concentration-time Curve (AUC) of AMG 592
Timeframe: Day 1 up to Day 57
Locations
Location
Research Site
Aventura, FL, United States, 33180
Status
Completed