Clinical trial NCT05056246: Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Maridebart Cafraglutide
Japanese participants
Caucasian participants
AMG 133
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133
timeFrame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
measure: Cmax of Total AMG 133
timeFrame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133
timeFrame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
measure: AUClast of Total AMG 133
timeFrame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
measure: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133
timeFrame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
measure: AUCinf of Total AMG 133
timeFrame: 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:
measure: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 to Day 120
measure: Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result
timeFrame: Days 1, 15, 29, 57 and 120
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global LLC
state: California
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: