Phase 1
Completed N=32
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
Source: ClinicalTrials.gov NCT04987333 ↗Enrolled (actual)
32
Serious AEs
6.3%
Results posted
Mar 2024
Primary outcomePrimary: Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa — 26.9; 41.6; 48.1; 56.1 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa |
26.9; 41.6; 48.1; 56.1 | — |
| PRIMARY Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa |
24.0; 24.0; 24.0; 20.0 | — |
| PRIMARY Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa |
1530; 2330; 2590; 2660 | — |
| PRIMARY Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa |
1700; 2350; 2590; 2500 | — |
| SECONDARY Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) |
8; 8; 8; 8; 1; 0 | — |
| SECONDARY Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies |
6; 7; 7; 7; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female participants, between 18 and 55 years of age (inclusive) at the time of Screening.
- 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.
- 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).
- Body mass index between 17 and 30 kg/m^2 (inclusive) at the time of Screening.
Exclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT04987333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.