Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: AMG 133

Study type: Interventional

Funder types: Industry

Identifiers

NCT05056246

20200290

Details and patient eligibility

About

The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Healthy male or female participants between 18 and 65 years of age (inclusive) at the time of Screening (Japanese participants must be first-generation Japanese)
2. In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations
3. Body mass index between 18 and 30 kg/m^2 at the time of Screening
4. Females of nonchildbearing potential

Key Exclusion Criteria:

1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease
2. History or current signs or symptoms of cardiovascular disease
3. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in
4. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
5. Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening
6. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in
7. Use of tobacco- or nicotine-containing products within 6 months prior to Check-in
8. Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in
9. Female participants with a positive pregnancy test at Screening or Check-in
10. Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit
11. Donation of blood from 3 months prior to Check-in, plasma from 2 weeks prior to Check-in, or platelets from 6 weeks prior to Check-in
12. Unwilling to abide with study restrictions

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 5 patient groups

Japanese Participants: AMG 133 Low Dose

Experimental group

Description:

Healthy Japanese participants will receive the low dose of AMG 133 as a SC injection on Day 1 of the study.

Treatment:

Drug: AMG 133

Japanese Participants: AMG 133 Medium Dose

Experimental group

Description:

Healthy Japanese participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.

Treatment:

Drug: AMG 133

Japanese Participants: AMG 133 High Dose

Experimental group

Description:

Healthy Japanese participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.

Treatment:

Drug: AMG 133

Caucasian Participants: AMG 133 Medium Dose

Experimental group

Description:

Healthy Caucasian participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.

Treatment:

Drug: AMG 133

Caucasian Participants: AMG 133 High Dose

Experimental group

Description:

Healthy Caucasian participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.

Treatment:

Drug: AMG 133