Study Complete
Sponsor ID
20140324

A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants

Sponsor ID
20140324
Clinicaltrials.gov ID
NCT05873907
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 592
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
64
Additional Study Details

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
Status
Contact Us
Location
Research Site
Aventura, FL, United States, 33180
Status
Completed