A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAmgen
About this trial
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants
Eligibility criteria
Qualifiers
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/m² (inclusive) and body weight ≥40 kg.
In good general health based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- AMG 691
Treatment groups
28 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov