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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056246
• Other study ID #: 20200290
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: September 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• AMG 133
Solution for injection

Locations

Country	Name	City	State
United States	WCCT Global LLC	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of AMG 133		Up to approximately 17 weeks
Primary	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
Primary	Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133		Up to approximately 17 weeks
Secondary	Number of Participants who Experienced an Adverse Event (AE)	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.	Up to approximately 17 weeks
Secondary	Number of Participants with Incidence of Anti-AMG 133 Antibodies		Up to approximately 17 weeks

External Links

•   AmgenTrials clinical trials website