BGM0504 20 mg tablets in healthy Chinese adults

A Randomized, Open-label, Multiple-dose Phase I Clinical Study to Evaluate the Effect of a High-fat Meal and Different Dosing Conditions on the Pharmacokinetics of BGM0504 Tablets in Healthy Chinese Participants.

This study will test how 20 mg BGM0504 tablets are absorbed and tolerated in healthy Chinese adults when taken with different meals, water amounts, and fasting times.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07566572 on ClinicalTrials.gov

What this trial studies

This randomized, open-label, multiple-dose Phase 1 trial gives healthy Chinese volunteers 20 mg BGM0504 tablets under varied administration conditions to measure pharmacokinetics and tolerability. Participants are assigned to dosing conditions that change meal fat content, water intake, and fasting duration to see how these factors affect drug absorption. Serial blood sampling will define PK parameters and safety monitoring will include vital signs, laboratory tests, and ECGs. The trial is conducted at Hangzhou First People's Hospital and enrolls generally healthy adults meeting specific age, weight, and BMI criteria.

Who should consider this trial

Good fit: Healthy Chinese adults aged 18–55 with weight ≥50 kg and BMI between 24.0 and <30 kg/m² who are medically stable and agree to required contraceptive measures are ideal candidates.

Not a fit: People with significant medical conditions, known severe drug allergies, pregnancy or breastfeeding, or those outside the specified age/BMI ranges are unlikely to benefit from or be eligible for this study.

Why it matters

Potential benefit: If successful, the results could guide dosing and meal/water recommendations to ensure predictable absorption and safety of BGM0504 in later patient studies.

How similar studies have performed: Food-effect and administration-condition PK studies are a routine part of early drug development and often show meaningful changes in absorption, but no public clinical results for BGM0504 are available.

Eligibility criteria

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 significance;
  * (Medical Inquiry/Examination) Individuals who previously had obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), affected gastric emptying (such as pyloric stenosis), or had undergone any gastrointestinal surgery (except for intestinal polyp resection and appendectomy), or had acute diarrhea, constipation within the 7 days before randomization; Diarrhea is defined as watery stools and/or daily defecation ≥ 3 times. Constipation is defined as the inability to achieve at least one defecation per day;
  * (Medical Inquiry/Examination) During the screening, individuals with acute cholecystitis, chronic cholecystitis; or those with symptomatic or treatable gallstones at the time of screening; or those with symptomatic or treatable gallbladder polyps at the time of screening;
  * (Medical Inquiry) Individuals previously diagnosed with thyroid C-cell carcinoma, MEN (Multiple Endocrine Adenoma Disease) type 2A or 2B, or with a related family history;
  * (Medical Inquiry) Individuals previously diagnosed with acute or chronic pancreatitis, or pancreatic injury;
  * (Medical Inquiry/Query) Individuals who used any prescription drugs or over-the-counter drugs (including chemical drugs, vitamin drugs, herbal drugs, etc.) within 2 weeks before screening;
  * (Examination) Individuals with any positive results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody during the screening period;
  * (Examination) At the screening/baseline, 12-lead electrocardiogram shows a heart rate of \< 50 beats per minute or \> 100 beats per minute, second or third degree atrioventricular conduction block, long QT syndrome or for women QTcF \> 470 ms or for men \> 450 ms or other electrocardiogram abnormalities judged by the investigator as requiring drug intervention;
  * (Medical Inquiry) Individuals with a history of fainting during blood transfusion or needle phobia;
  * (Medical Inquiry) Individuals who have taken drugs or had drug abuse history within 6 months before screening;
  * (Medical Inquiry) Individuals who smoked more than 10 cigarettes per day on average (including nicotine replacement products) within 3 months before screening, or who could not prohibit smoking throughout the trial stay;
  * (Medical Inquiry) Individuals who frequently drank alcohol within the 3 months before screening, that is, with an average daily alcohol intake of more than 2 units (1 unit = 17.7 mL ethanol, that is, 1 unit = 357 mL alcohol for 5% beer or 43 mL alcohol for 40% liquor or 147 mL alcohol for 12% wine) or who could not abstain from alcohol throughout the trial stay;
  * (Medical Inquiry) Individuals who donated blood or lost more than 400 mL of blood within 3 months before screening or plan to donate blood during or after the trial;
  * (Medical Inquiry/Query) Individuals who participated in drug or medical device clinical trials and received trial drugs (except for placebo) or medical device interventions within 3 months before screening;
  * (Medical Inquiry) Individuals who received any vaccine or plan to receive a vaccine during screening;
  * (Medical Inquiry/Examination) Female participants who are pregnant or lactating, or those with positive pregnancy test results during the screening period;
  * (Examination) Individuals with positive urine drug or alcohol breath screening at the baseline period;
  * Individuals determined by the investigator to be unsuitable to participate in this study or who withdrew from the study for personal reasons

Where this trial is running

Hangzhou, Zhejiang

• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Conditions Chinese Healthy Volunteers