Actively Recruiting
A Study of BGM0504 Tablets in Healthy Chinese Subjects
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2026-05-05
144
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
B
BrightGene Bio-Medical Technology Co., Ltd.
Lead Sponsor
B
BrightGene Pharmaceutical (Suzhou) Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of BGM0504 Tablets in Healthy Chinese Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 55 years (inclusive) at the time of screening, both male and female
- Weight at least 50 kg
- Body mass index (BMI) between 24.0 kg/m² and less than 30 kg/m²
- Stable body weight with less than 5% change during the previous 12 weeks
- Willing to use effective contraceptive measures from signing informed consent until 3 months after last dose
- No plans for sperm or egg donation
- Determined to be generally healthy by investigator based on medical history, physical exam, vital signs, lab tests, and electrocardiogram
You will not qualify if you...
- History of severe drug allergies or severe specific allergic diseases or severe allergic constitution
- History or current major diseases of nervous, cardiovascular, digestive, respiratory, urinary, endocrine, blood, or immune systems
- Laboratory test results judged abnormal and clinically significant by investigator
- History of obvious gastrointestinal diseases or related symptoms, affected gastric emptying, prior gastrointestinal surgery (except polyp resection and appendectomy), or acute diarrhea/constipation within 7 days before randomization
- Acute or chronic cholecystitis, symptomatic or treatable gallstones, or gallbladder polyps at screening
- Diagnosis or family history of thyroid C-cell carcinoma or MEN type 2A or 2B
- Diagnosis of acute or chronic pancreatitis or pancreatic injury
- Use of any prescription or over-the-counter drugs within 2 weeks before screening
- Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibody during screening
- Electrocardiogram showing heart rate <50 bpm or >100 bpm, certain conduction blocks, long QT syndrome, or other abnormalities requiring intervention
- History of fainting during blood transfusion or needle phobia
- History of drug abuse or use within 6 months before screening
- Smoking more than 10 cigarettes per day within 3 months before screening or unable to stop smoking during study
- Frequent alcohol intake exceeding 2 units daily within 3 months before screening or unable to abstain during study
- Blood donation or blood loss over 400 mL within 3 months before screening or plans to donate during/after study
- Participation in drug or device clinical trials with active treatment within 3 months before screening
- Receipt or planned receipt of any vaccine during screening
- Female pregnancy or lactation or positive pregnancy test during screening
- Positive urine drug or alcohol breath test at baseline
- Investigator judgment deeming participant unsuitable or withdrawal for personal reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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