A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 691 Administered in Healthy Chinese and Japanese Participants
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 60 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests AMG 691 in healthy Chinese and Japanese adults ages 18 to 60. It checks how the drug moves through the body, its safety and side effects, and how the body's immune system reacts to it.
The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Healthy men or women ages 18 to 60.
- Chinese ancestry: born in China, Hong Kong, Taiwan, or Macau, with 2 Chinese parents and 4 Chinese grandparents.
- Japanese ancestry: born in Japan, with 2 Japanese parents and 4 Japanese grandparents. Either this or the Chinese ancestry rule must be met.
- Body mass index (BMI), a measure of weight compared to height, from 18 to 30, and weight at least 40 kg.
- Good general health based on health history, an exam, heart tracing (ECG), and other health tests.
- Women must not be pregnant or breastfeeding.
- People who can have children must follow the study's birth control rules.
- Willing to keep their usual diet and level of physical activity during the study.
Who can't join
- A major health problem or test finding that could affect the study, including abnormal heart tracing, blood pressure, or pulse; kidney or liver tests outside study limits.
- Past cancer, except certain early cervical cancers or non-melanoma skin cancers treated more than 5 years before dosing; a blood clot in a deep vein or lung within 3 months.
- Past allergic reactions to biologic medicines, products from mammals, or AMG 691 ingredients; a history of a weakened immune system.
- Current or recurring infection; a severe infection needing antibiotics through a vein within 3 years; a positive or unclear TB test; untreated or ongoing parasitic worm infection; positive HIV or hepatitis B or C tests.
- A live vaccine within 12 weeks before check-in or planned during the study; use of medicines or supplements the study does not allow, unless the study doctor approves.
- Illegal drug use within 1 year, a positive drug test, or unwillingness to avoid illegal drugs and cannabis products; tobacco or nicotine use within 6 months; alcohol abuse or heavy drinking.
- Self-harm without intent to die within 5 years; unstable major depression or another severe mental health disorder within 2 years.
- Another study drug within the stated waiting period; past AMG 691 use; recent blood, plasma, or platelet donation; unwillingness to follow study rules or being judged unsuitable by the study doctor.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
NV
- PPD - Las Vegas Research Unit · Las Vegas, NV 89113More trials in Las Vegas