Phase 1
Completed N=34
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
Healthy Participants
Source: ClinicalTrials.gov NCT05056246 ↗
Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Feb 2025
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133 — 12.3; 22.7; 44.9; 22.5 μg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133 |
12.3; 22.7; 44.9; 22.5; 55.0 | — |
| PRIMARY Cmax of Total AMG 133 |
13.2; 24.8; 48.4; 20.8; 58.7 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133 |
10600; 19400; 33500; 17200; 35700 | — |
| PRIMARY AUClast of Total AMG 133 |
14800; 28300; 47700; 20800; 49600 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133 |
10700; 19600; 33900; 17300; 36000 | — |
| PRIMARY AUCinf of Total AMG 133 |
15600; 30100; 50100; 21800; 51500 | — |
| SECONDARY Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) |
6; 6; 7; 7; 7 | — |
| SECONDARY Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result |
3; 3; 3; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05056246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.