Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
- Registration Number
- NCT04987333
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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Healthy male or female participants, between 18 and 55 years of age (inclusive) at the time of Screening.
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Chinese, Japanese, or Caucasian participant:
- Chinese participants must be of Chinese ancestry (4 grandparents and biological parents).
- Japanese participants must be first- or second-generation Japanese (4 grandparents and biological parents; participant or both of their parents must have been born in Japan).
- Caucasian participants are those who self-identify exclusively as such on the electronic case report form (eCRF) and also identify their biological parents as such.
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In good health, determined by no clinically significant findings from medical history, physical examinations, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the Investigator (or designee).
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Body mass index between 17 and 30 kg/m^2 (inclusive) at the time of Screening.
- Evidence of scars, tattoos, or other skin lesions that may interfere with the injection site or injection site assessments.
- History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
- A QT interval corrected for heart rate using Fridericia's method (QTcF) interval > 450 msec in male participants or > 470 msec in female participants or history/evidence of long QT syndrome, at Screening or Check-in.
- PR interval > 210 msec, at Screening or Check-in.
- Second- or third-degree atrioventricular (AV) block , at Screening or Check-in.
- Systolic blood pressure (BP) > 140 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg, or HR > 100 bpm, at Screening or Check-in.
- Estimated glomerular filtration rate less than 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation, at Screening.
- HbA1C ≥ 7%, at Screening or Check-in.
- Participants who have received live vaccines within 5 weeks prior to Screening, or plan to receive live vaccines within 105 days after administration of an investigational product.
- Positive hepatitis B or hepatitis C panel (ie, positive hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibody) at Screening, or a medical history for hepatitis B or C; and/or positive human immunodeficiency virus test, at Screening. Participants whose results are compatible with prior vaccination may be included. Participants with a history of hepatitis B vaccination without a history of hepatitis B or C are allowed to participate.
- Consumption of foods and beverages containing poppy seeds within 7 days prior to Check-in.
- History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
- Use of tobacco- or nicotine-containing products within 6 months prior to Check-in.
- Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in.
- Female participants with a positive pregnancy test at Screening or Check-in.
- Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives of the drug, whichever is longer, prior to Check-in.
- Donation of blood from 90 days prior to Check-in, plasma from 2 weeks prior to Check-in, or platelets from 6 weeks prior to Check-in.
- Participants with abnormal laboratory results for alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (ie, > upper limit of normal) and total bilirubin (ie, > upper limit of normal) at Screening and Check-in.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 4: Caucasian participants - efavaleukin alfa dose level 2 Efavaleukin alfa Caucasian participants will receive a single dose of efavaleukin alfa at dose level 2. Group 2: Chinese participants - efavaleukin alfa dose level 2 Efavaleukin alfa Chinese participants will receive a single dose of efavaleukin alfa at dose level 2. Group 3: Japanese participants - efavaleukin alfa dose level 2 Efavaleukin alfa Japanese participants will receive a single dose of efavaleukin alfa at dose level 2. Group 1: Chinese participants - efavaleukin alfa dose level 1 Efavaleukin alfa Chinese participants will receive a single dose of efavaleukin alfa at dose level 1.
- Primary Outcome Measures
Name Time Method Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa 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 Blood samples were collected to determine PK parameters.
Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa 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 Blood samples were collected to determine PK parameters.
Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa 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 Blood samples were collected to determine PK parameters.
Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa 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 Blood samples were collected to determine PK parameters.
- Secondary Outcome Measures
Name Time Method Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies Day 1 up to Day 43 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.
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) Day 1 to Day 43 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
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit - Leeds
🇬🇧Leeds, LDS, United Kingdom