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OpenTrials
Completed

NCT Number: NCT05056246

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global LLC

Cypress, California, 90630-4738, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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

Treatment and study plan

AMG 133

Drug

Solution for SC injection

Other names: maridebart cafraglutide

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133

    Time frame: 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.

  2. Cmax of Total AMG 133

    Time frame: 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.

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

    Time frame: 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.

  4. AUClast of Total AMG 133

    Time frame: 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.

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

    Time frame: 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.

  6. AUCinf of Total AMG 133

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase I, Open-label, Randomized, Parallel-arm, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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