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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Administered as a single dose SC injection.
Labcorp Clinical Research Unit - Leeds
Leeds, LDS, United Kingdom
Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa
Blood samples were collected to determine PK parameters.
Time frame: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43
Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa
Blood samples were collected to determine PK parameters.
Time frame: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43
Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa
Blood samples were collected to determine PK parameters.
Time frame: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43
Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa
Blood samples were collected to determine PK parameters.
Time frame: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Adverse events (AEs) were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment. Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs were recorded as TEAEs. Serious AEs (SAEs) were defined as any event that met at least 1 of the following serious criteria: * Resulted in death (fatal) * Required in-patient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly/birth defect * Other medically important serious event
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Time frame: Day 1 to Day 43
Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies
Number of participants who tested positive for developing anti-efavaleukin alfa antibodies and/or anti-IL2 antibodies at 1 or more post-baseline time points, who had a negative or no result at baseline.
Time frame: Day 1 up to Day 43