A Study of BGM0504 Tablets in Healthy Chinese Subjects
ConditionChinese Healthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBrightGene Bio-Medical Technology Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
○ 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.
Disqualifiers
● (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;
Trial design
Treatments tested in this trial
- BGM0504 tablets
Treatment groups
144 Participants
are divided into 1 treatment groupSponsors and collaborators
BrightGene Bio-Medical Technology Co., Ltd.
Lead sponsor
BrightGene Pharmaceutical (Suzhou) Co., LTD
Collaborator
Source ClinicalTrials.gov