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Completed

NCT Number: NCT04987333

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit - Leeds

Leeds, LDS, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efavaleukin alfa

Drug

Administered as a single dose SC injection.

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa

    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

    Blood samples were collected to determine PK parameters.

  2. Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa

    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

    Blood samples were collected to determine PK parameters.

  3. Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa

    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

    Blood samples were collected to determine PK parameters.

  4. Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa

    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

    Blood samples were collected to determine PK parameters.

Secondary outcomes

  1. Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)

    Time frame: 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
  2. Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2021
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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