A Study of BGM0504 Tablets in Healthy Chinese Subjects (NCT07566572) | Clinical Trial Compass
RecruitingPhase 1
A Study of BGM0504 Tablets in Healthy Chinese Subjects
China144 participantsStarted 2026-03-26
Plain-language summary
A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female;
* weight ≥ 50 kg, and body mass index (BMI): 24.0 kg/m² ≤ BMI \< 30 kg/m²(BMI = weight/height²);
* (Medical Inquiry) Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening.
* Participants should be willing to take effective contraceptive measures from the date of signing the informed consent form until 3 months after the last administration, and have no plans for sperm or egg donation.
* Participants who were determined to be generally healthy by the investigator based on their past medical history, physical examination, vital signs, laboratory tests and electrocardiogram examinations.
Exclusion Criteria:
* ● (Medical Inquiry) Individuals with a history of severe drug allergies (especially known or suspected allergies to the components and excipients of BGM0504 tablets) or those with severe specific allergic diseases/diseases history or severe allergic constitution;
* (Medical Inquiry) Individuals who have previously suffered from or currently have major diseases in the nervous system, cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, blood system or immune system, and are judged by the investigator to be unsuitable to participate in this trial;
* (Examination) Any laboratory test results judged by the investigator as abnormal and of clinical significan…