Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • BGM0504 tablets

    Drug

    Administered p.o.

Treatment groups

144 Participants
are divided into 1 treatment group
Group A: BGM0504 tabletsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetic (PK) endpoint： AUC0-tau,ss

Time frame
4 weeks
2

PK endpoint：Cmax,ss

Time frame
4 weeks
3

PK endpoint：t1/2,ss

Time frame
4 weeks

Secondary outcomes

1

Pharmacodynamics (PD) endpoint：Changes in fasting blood glucose

Time frame
6 weeks
2

PD endpoint：waist circumference before and after administration

Time frame
6 weeks
3

PD endpoint：body weight before and after administration

Time frame
6 weeks
4

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrightGene Bio-Medical Technology Co., Ltd.

Lead sponsor

BrightGene Pharmaceutical (Suzhou) Co., LTD

Collaborator

Source ClinicalTrials.gov
Apply now