A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers

NCT07745907 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20240037
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants

Conditions

Healthy Participants

Keywords

AMG 691; Respiratory Tract Diseases; Asthma; Lung Diseases

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Serum Concentration (Cmax) of AMG 691

  Day 1 up to Day 154

• Area Under the Serum Concentration Time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of AMG 691

  Up to Day 154

• Area Under the Serum concentration Time Curve from Time Zero to Infinity (AUC0-inf) of AMG 691

  Up to Day 154

Secondary Outcomes (3)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Day 1 to end of trial (approximately 154 days)

• Number of Participants with Serious Adverse Events (SAEs)

  From screening (Day -28) up to end of trial (approximately 154 days)

• Number of Participants Who Develop Anti-AMG 691 Antibodies

  Up to Day 154

Study Arms (4)

Cohort 1

EXPERIMENTAL

Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC)

Drug: AMG 691

Cohort 2

EXPERIMENTAL

Japanese participants will receive AMG 691 at the Level A dose administered SC

Drug: AMG 691

Cohort 3

EXPERIMENTAL

Chinese participants will receive AMG 691 at the Level B dose administered SC

Drug: AMG 691

Cohort 4

EXPERIMENTAL

Japanese participants will receive AMG 691 at the Level B dose administered SC

Drug: AMG 691

Interventions

AMG 691 DRUG

AMG 691 will be administered subcutaneously

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female participants, 18 to 60 years of age.
• 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).
• Body mass index (BMI) 18.0 to 30.0 kg/m\^2 (inclusive) and body weight ≥40 kg.
• In good general health based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
• Female participants must not be pregnant or breastfeeding.
• Participants of reproductive potential must agree to follow protocol-specified contraception requirements.
• Willing to maintain usual diet and physical activity regimen throughout study participation.

You may not qualify if:

• Clinically significant medical condition, disease, or abnormal finding that could interfere with study participation or interpretation of results.
• Clinically significant ECG abnormalities
• Clinically significant abnormal blood pressure or pulse rate at screening/check-in.
• History of malignancy (except adequately treated in situ cervical cancer or non-melanoma skin cancer \>5 years before dosing).
• Deep vein thrombosis or pulmonary embolism within 3 months prior to check-in.
• History of hypersensitivity/anaphylaxis to biologic therapies, mammalian-derived products, or AMG 691 excipients.
• Active, chronic, recurrent, or unresolved infection; history of severe infection requiring intravenous (IV) antibiotics within the past 3 years.
• Positive or indeterminate QuantiFERON-TB Gold test.
• Untreated or unresolved helminth parasitic infection.
• History of immunodeficiency.
• Receipt of live or live-attenuated vaccines within 12 weeks before check-in or planned during the study.
• Estimated glomerular filtration rate (eGFR) \<70 mL/min/1.73 m\^2.
• Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or direct bilirubin \>1.5 × Upper Limit Normal (ULN).
• Positive screening tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
• Use of prohibited prescription, over-the-counter, herbal, vitamin, or dietary supplement products within 30 days (or 5 half-lives) before enrollment, unless approved by the investigator.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

PPD - Las Vegas Research Unit

Las Vegas, Nevada, 89113, United States

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Respiratory Tract Diseases; Asthma; Lung Diseases

Condition Hierarchy (Ancestors)

Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 7, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (1)