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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: AMG 133


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Japanese participants - AMG 133 low dose<br>Japanese participants will receive the low dose of AMG 133 administered via subcutaneous injection. | Drug: AMG 133<br>* Solution for injection<br>|
| Experimental: Group 2: Japanese participants - AMG 133 medium dose<br>Japanese participants will receive the medium dose of AMG 133 administered via subcutaneous injection. | Drug: AMG 133<br>* Solution for injection<br>|
| Experimental: Group 3: Japanese participants - AMG 133 high dose<br>Japanese participants will receive the high dose of AMG 133 administered via subcutaneous injection. | Drug: AMG 133<br>* Solution for injection<br>|
| Experimental: Group 4: Caucasian participants - AMG 133 medium dose<br>Caucasian participants will receive the medium dose of AMG 133 administered via subcutaneous injection. | Drug: AMG 133<br>* Solution for injection<br>|
| Experimental: Group 5: Caucasian participants - AMG 133 high dose<br>Japanese participants will receive the high dose of AMG 133 administered via subcutaneous injection. | Drug: AMG 133<br>* Solution for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of AMG 133 |  | Up to approximately 17 weeks | 
| 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 | 
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133 |  | Up to approximately 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of Participants with Incidence of Anti-AMG 133 Antibodies |  | Up to approximately 17 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMG 133, Japanese participants, Caucasian participants