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

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: AMG 133

Registration Number: NCT05056246

Lead Sponsor: Amgen

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

Inclusion Criteria

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)
In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations
Body mass index between 18 and 30 kg/m^2 at the time of Screening
Females of nonchildbearing potential

Key

Exclusion Criteria

History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease
History or current signs or symptoms of cardiovascular disease
History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in
History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening
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
Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit
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
Unwilling to abide with study restrictions

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Japanese Participants: AMG 133 Low Dose	AMG 133	Healthy Japanese participants will receive the low dose of AMG 133 as a SC injection on Day 1 of the study.
Japanese Participants: AMG 133 Medium Dose	AMG 133	Healthy Japanese participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.
Japanese Participants: AMG 133 High Dose	AMG 133	Healthy Japanese participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.
Caucasian Participants: AMG 133 High Dose	AMG 133	Healthy Caucasian participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.
Caucasian Participants: AMG 133 Medium Dose	AMG 133	Healthy Caucasian participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133	Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose	Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Cmax of Total AMG 133	Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose	Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133	Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose	Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
AUClast of Total AMG 133	Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose	Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133	Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose	Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
AUCinf of Total AMG 133	Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose	Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	Day 1 to Day 120	A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with AMG 133 that started during or after dosing, or started prior to dosing and increased in severity after dosing. Clinically significant changes from baseline in clinical laboratory tests, 12-lead electrocardiograms (ECGs) and vital signs were also reported as TEAEs.
Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result	Days 1, 15, 29, 57 and 120	Blood samples were collected at specific times during the study for the measurement of anti-AMG 133 binding antibodies from participants who received AMG 133.