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

Inflammatory Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987333
• Other study ID #: 20200102
• Status: Completed
• Phase: Phase 1
• Start date: August 9, 2021
• Est. completion date: October 3, 2022

Study information

• Verified date: October 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Diseases

Intervention

Drug:
• Efavaleukin alfa
Administered as a single dose SC injection.

Locations

Country	Name	City	State
United Kingdom	Labcorp Clinical Research Unit - Leeds	Leeds	LDS

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa	Blood samples were collected to determine PK parameters.	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
Primary	Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa	Blood samples were collected to determine PK parameters.	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
Primary	Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa	Blood samples were collected to determine PK parameters.	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
Primary	Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa	Blood samples were collected to determine PK parameters.	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	Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)	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	Day 1 to Day 43
Secondary	Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies	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.	Day 1 up to Day 43

External Links

•   AmgenTrials clinical trials website