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Pharmacokinetics, Safety and Tolerability Evaluation of AMG 691 in Healthy Chinese and Japanese Participants

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Study Aim

This study aims to evaluate the safety, tolerability, and how the body processes AMG 691 in healthy Chinese and Japanese participants.

What is being tested

Study of AMG 691 Drug

+ Study of AMG 691 Drug

+ Study of AMG 691 Drug

Drug
Who is being recruted

Bronchial Diseases+6

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 18 to 60 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 1
Interventional
Study Start: August 2026
See protocol details

Summary

Principal SponsorAmgen
Study ContactAmgen Call Center
Last updated: August 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 7, 2026

Actual date on which the first participant was enrolled.

This study focuses on understanding the effects of a drug called AMG 691 in healthy Chinese and Japanese participants. The primary goal is to examine how this drug behaves within the body, specifically how it is absorbed, distributed, metabolized, and eliminated. This is known as pharmacokinetics. Additionally, the study aims to evaluate the safety and tolerability of AMG 691 in these participants, which is crucial in determining if the drug causes any side effects or adverse reactions. The study is important as it contributes to the basic science understanding of this drug, potentially paving the way for its future use in treating various conditions. Participants in this study will receive a single dose of AMG 691. The study will measure the maximum observed concentration of AMG 691 in the blood (Cmax), the total exposure to AMG 691 over time (Area Under the Serum Concentration Time Curve, or AUC), and how long the drug stays in the body. These measurements help researchers understand how the drug works in the body and how it might affect different individuals. As with any clinical trial, there may be potential risks and benefits associated with participating, which will be fully explained to participants before they decide to take part.

NCT07745907
Principal SponsorAmgen
Study ContactAmgen Call Center
Last updated: August 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityAsthmaLung DiseasesRespiratory Tract Diseases

Criteria

7 inclusion criteria required to participate
Body mass index (BMI) 18.0 to 30.0 kg/m\^2 (inclusive) and body weight >= 40 kg
Female participants must not be pregnant or breastfeeding
First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Japanese grandparents)
Healthy male or female participants, 18 to 60 years of age
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23 exclusion criteria prevent from participating
Active, chronic, recurrent, or unresolved infection; history of severe infection requiring intravenous (IV) antibiotics within the past 3 years
Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or direct bilirubin > 1.5 x Upper Limit Normal (ULN)
Any participant considered unsuitable by the investigator or unwilling to comply with study restrictions
Clinically significant ECG abnormalities
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This group is for Chinese participants who will receive AMG 691 drug via a subcutaneous injection (under the skin).

Group II

Experimental
Japanese participants in this group will receive the drug AMG 691 at a specific dose, given under the skin (subcutaneously).

Group III

Experimental
This group is for Chinese participants who will receive AMG 691 at the Level B dose, given under the skin (subcutaneously).

Group IV

Experimental
This group is for Japanese participants who will receive AMG 691 at the Level B dose, given as a subcutaneous injection.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

PPD - Las Vegas Research Unit

Las Vegas, United StatesOpen PPD - Las Vegas Research Unit in Google Maps
Recruiting
One Study Center