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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-04-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Japanese Participants: AMG 133 Low Dose

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

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

Solution for SC injection

Japanese Participants: AMG 133 Medium Dose

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

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

Solution for SC injection

Japanese Participants: AMG 133 High Dose

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

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

Solution for SC injection

Caucasian Participants: AMG 133 Medium Dose

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

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

Solution for SC injection

Caucasian Participants: AMG 133 High Dose

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

Group Type EXPERIMENTAL

AMG 133

Intervention Type DRUG

Solution for SC injection

Interventions

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AMG 133

Solution for SC injection

Intervention Type DRUG

Other Intervention Names

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maridebart cafraglutide

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes