Study Complete
Sponsor ID
20200102

Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants

Sponsor ID
20200102
Clinicaltrials.gov ID
NCT04987333
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.

Additional Study Details

Phase
Phase 1
Product
AMG 592
Type
Interventional
Masking
None (Open Label)
Enrollment
32
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa

Timeframe: Up to Day 43

Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa

Timeframe: Up to Day 43

Area Under the Serum Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa

Timeframe: Up to Day 43

Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUCinf) of Efavaleukin Alfa

Timeframe: Up to Day 43

Secondary Outcome Measures

Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs)

Timeframe: Day 1 to Day 43

Incidences of Anti-Eflavaleukin Alfa and Anti-Interleukin 2 (IL-2) Antibody Formation

Timeframe: Up to Day 43

Locations

Location
Status
Contact Us
Location
Labcorp Clinical Research Unit - Leeds
Leeds, LDS, United Kingdom, LS2 9LH
Status
Recruiting