Phase 1 Study of AMG 691 Injection in Healthy Chinese and Japanese Adults Evaluating Drug Behavior and Safety

What this Trial Is About

Researchers are evaluating the pharmacokinetics, safety, tolerability, and immune response to the drug AMG 691 in healthy adult participants of Chinese and Japanese descent. This Phase 1 trial focuses on understanding how AMG 691 behaves in the body and its potential effects in these populations. The study includes healthy volunteers aged 18 to 60 years who meet specific ancestry and health criteria. Participants receive AMG 691 through subcutaneous injections at two different dose levels, referred to as Level A and Level B. Four groups are studied in parallel Chinese and Japanese participants each receive one of the two dose levels. The treatment is administered once, and participants are observed and assessed over a period of approximately 154 days following dosing. During the study, participants undergo various assessments including blood sampling to measure the maximum serum concentration and the area under the concentration-time curve of AMG 691. Safety monitoring includes tracking any adverse events and the development of antibodies against AMG 691. Other evaluations include physical exams, vital signs, electrocardiograms, and laboratory tests. The total participation lasts about five months, ensuring close observation of drug behavior and participant safety.

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