Clinical trial NCT04987333: Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
Official title: A Phase 1, Open-label, Sequential-group, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 592 Administered Subcutaneously in Healthy Chinese, Japanese, and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Diseases
Keywords: Systemic lupus erythematosus (SLE)
Steroid-refractory chronic graft-versus-host disease (GvHD)
Ulcerative colitis
Single-dose study
Efavaleukin alfa
Regulatory T Cells (Tregs)
Inflammatory
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa
timeFrame: 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
measure: Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa
timeFrame: 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
measure: Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa
timeFrame: 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
measure: Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa
timeFrame: 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
Secondary outcomes:
measure: Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 43
measure: Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies
timeFrame: Day 1 up to Day 43
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Labcorp Clinical Research Unit - Leeds
state: LDS
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: