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

Eligible age

18–60 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

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

Sponsor: Amgen

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.

Where it's recruiting

Nevada

Las Vegas

Source: ClinicalTrials.gov · NCT07745907 · last updated 2026-08-04

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