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RecruitingNCT07745907Updated Aug 27, 2026

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

A Phase 1 interventional study of AMG 691 in Healthy Participants, sponsored by Amgen. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Amgen · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Participants

Keywords

  • AMG 691
  • Respiratory Tract Diseases
  • Asthma
  • Lung Diseases
03

In context

Respiratory Tract Diseases

617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.

This study's planned enrollment of 28 is below the median of 80 across 381 interventional studies indexed under Respiratory Tract Diseases.

Browse Respiratory Tract Diseases studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Cohort 1

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

    Drug: AMG 691

  • Experimental
    Cohort 2

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

    Drug: AMG 691

  • Experimental
    Cohort 3

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

    Drug: AMG 691

  • Experimental
    Cohort 4

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

    Drug: AMG 691

Interventions

  • DrugAMG 691

    AMG 691 will be administered subcutaneously

06

What researchers measure

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of AMG 691

    Time frame: Day 1 up to Day 154

  2. 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

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

    Time frame: Up to Day 154

Secondary outcomes

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

    Time frame: Day 1 to end of trial (approximately 154 days)

  2. Number of Participants with Serious Adverse Events (SAEs)

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

  3. Number of Participants Who Develop Anti-AMG 691 Antibodies

    Time frame: Up to Day 154

07

Study locations

1 of 1 sites recruiting
  • PPD - Las Vegas Research Unit
    Las Vegas, Nevada 89113, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07745907
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
Aug 7, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Amgen Call Center
Contact
medinfo@amgen.com
866-572-6436
MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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