Recruiting
Phase 1

AMG 691

Sponsor:

Amgen

Code:

NCT07745907

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

AMG 691

Study Details

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

Study ID

NCT07745907

Start date

Aug 7, 2026

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cohort 1

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

experimental: Cohort 2

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

experimental: Cohort 3

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

experimental: Cohort 4

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

Interventions

AMG 691

AMG 691 will be administered subcutaneously

Primary outcome measure

  • Maximum Observed Serum Concentration (Cmax) of AMG 691 [ Time Frame: 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 [ Time Frame: Up to Day 154 ]
  • Area Under the Serum concentration Time Curve from Time Zero to Infinity (AUC0-inf) of AMG 691 [ Time Frame: Up to Day 154 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

PPD - Las Vegas Research Unit

Recruiting

Las Vegas, Nevada, United States, 89113

More Information

Sponsor

Amgen

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • AMG 691
  • Respiratory Tract Diseases
  • Asthma
  • Lung Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-27.