Study Complete
Sponsor ID
20200102
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
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.
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
Labcorp Clinical Research Unit - Leeds
Leeds, LDS, United Kingdom, LS2 9LH
Status
Recruiting