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

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 691 Administered in Healthy Chinese and Japanese Participants

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: AMG 691

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Recruiting
      • PPD - Las Vegas Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• History of illicit drug use within 1 year, positive drug screen, or unwillingness to abstain from illicit drugs/cannabinoids during the study.
• Use of tobacco or nicotine-containing products within 6 months prior to check-in.
• History of alcohol abuse or excessive alcohol consumption.
• History of non-suicidal self-injury within 5 years or unstable major depressive disorder/other severe psychiatric disorder within 2 years.
• Participation in another investigational drug study within 90 days (or 5 half-lives) prior to check-in.
• Previous exposure to AMG 691.
• Recent donation of blood, plasma, or platelets.
• Any participant considered unsuitable by the investigator or unwilling to comply with study restrictions.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC)	Drug: AMG 691; AMG 691 will be administered subcutaneously
Experimental: Cohort 2; Japanese participants will receive AMG 691 at the Level A dose administered SC	Drug: AMG 691; AMG 691 will be administered subcutaneously
Experimental: Cohort 3; Chinese participants will receive AMG 691 at the Level B dose administered SC	Drug: AMG 691; AMG 691 will be administered subcutaneously
Experimental: Cohort 4; Japanese participants will receive AMG 691 at the Level B dose administered SC	Drug: AMG 691; AMG 691 will be administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; Respiratory Tract Diseases; Lung Diseases; AMG 691
• Additional Relevant MeSH Terms: Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Lung Diseases; Asthma; Respiratory Tract Diseases
• Other Study ID Numbers: 20240037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No