Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants

NCT ID: NCT04987333

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2022-10-03

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.

Conditions

Inflammatory Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Chinese participants - efavaleukin alfa dose level 1

Chinese participants will receive a single dose of efavaleukin alfa at dose level 1.

Group Type: EXPERIMENTAL

Efavaleukin alfa

Intervention Type: DRUG

Administered as a single dose SC injection.

Group 2: Chinese participants - efavaleukin alfa dose level 2

Chinese participants will receive a single dose of efavaleukin alfa at dose level 2.

Group Type: EXPERIMENTAL

Efavaleukin alfa

Intervention Type: DRUG

Administered as a single dose SC injection.

Group 3: Japanese participants - efavaleukin alfa dose level 2

Japanese participants will receive a single dose of efavaleukin alfa at dose level 2.

Group Type: EXPERIMENTAL

Efavaleukin alfa

Intervention Type: DRUG

Administered as a single dose SC injection.

Group 4: Caucasian participants - efavaleukin alfa dose level 2

Caucasian participants will receive a single dose of efavaleukin alfa at dose level 2.

Group Type: EXPERIMENTAL

Efavaleukin alfa

Intervention Type: DRUG

Administered as a single dose SC injection.

Interventions

Efavaleukin alfa

Administered as a single dose SC injection.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Labcorp Clinical Research Unit - Leeds

Leeds, LDS, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20200102

Identifier Type: -

Identifier Source: org_study_id