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

NCT05056246 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20200290
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Maridebart Cafraglutide; Japanese participants; Caucasian participants; AMG 133

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133

  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.

  Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

• Cmax of Total AMG 133

  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.

  Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

• Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133

  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.

  Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

• AUClast of Total AMG 133

  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.

  Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

• Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133

  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.

  Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

• AUCinf of Total AMG 133

  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.

  Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

Secondary Outcomes (2)

• Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

  Day 1 to Day 120

• Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result

  Days 1, 15, 29, 57 and 120

Study Arms (5)

Japanese Participants: AMG 133 Low Dose

EXPERIMENTAL

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

Drug: AMG 133

Japanese Participants: AMG 133 Medium Dose

EXPERIMENTAL

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

Drug: AMG 133

Japanese Participants: AMG 133 High Dose

EXPERIMENTAL

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

Drug: AMG 133

Caucasian Participants: AMG 133 Medium Dose

EXPERIMENTAL

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

Drug: AMG 133

Caucasian Participants: AMG 133 High Dose

EXPERIMENTAL

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

Drug: AMG 133

Interventions

AMG 133 DRUG

Solution for SC injection

Also known as: maridebart cafraglutide

Caucasian Participants: AMG 133 High Dose; Caucasian Participants: AMG 133 Medium Dose; Japanese Participants: AMG 133 High Dose; Japanese Participants: AMG 133 Low Dose; Japanese Participants: AMG 133 Medium Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

WCCT Global LLC

Cypress, California, 90630-4738, United States

Location

Related Links

• AmgenTrials clinical trials website

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 24, 2021
• Study Start: September 10, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (1)