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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05056246
Collaborator
(none)
34
Enrollment
1
Location
5
Arms
5.5
Actual Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: AMG 133
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Sep 28, 2021
Actual Primary Completion Date :
Mar 15, 2022
Actual Study Completion Date :
Mar 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: Japanese participants - AMG 133 low dose

Japanese participants will receive the low dose of AMG 133 administered via subcutaneous injection.

Drug: AMG 133
Solution for injection
Experimental: Group 2: Japanese participants - AMG 133 medium dose

Japanese participants will receive the medium dose of AMG 133 administered via subcutaneous injection.

Drug: AMG 133
Solution for injection
Experimental: Group 3: Japanese participants - AMG 133 high dose

Japanese participants will receive the high dose of AMG 133 administered via subcutaneous injection.

Drug: AMG 133
Solution for injection
Experimental: Group 4: Caucasian participants - AMG 133 medium dose

Caucasian participants will receive the medium dose of AMG 133 administered via subcutaneous injection.

Drug: AMG 133
Solution for injection
Experimental: Group 5: Caucasian participants - AMG 133 high dose

Japanese participants will receive the high dose of AMG 133 administered via subcutaneous injection.

Drug: AMG 133
Solution for injection

Outcome Measures

Primary Outcome Measures

  1. Maximum Observed Plasma Concentration (Cmax) of AMG 133 [Up to approximately 17 weeks]

  2. Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133 [Up to approximately 17 weeks]

  3. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133 [Up to approximately 17 weeks]

Secondary Outcome Measures

  1. Number of Participants who Experienced an Adverse Event (AE) [Up to approximately 17 weeks]

    An AE is defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. Any clinically significant clinical laboratory tests, 12-lead electrocardiograms (ECGs) and vital signs will also be recorded as AEs.

  2. Number of Participants with Incidence of Anti-AMG 133 Antibodies [Up to approximately 17 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 WCCT Global LLC Cypress California United States 90630-4738

Sponsors and Collaborators

  • Amgen

Investigators

  • Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT05056246
Other Study ID Numbers:
  • 20200290
First Posted:
Sep 24, 2021
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amgen
AMG 133
Japanese participants
Caucasian participants

Study Results

No Results Posted as of Mar 18, 2022