Healthy, Non-diabetic Overweight or Obese
Conditions
Brief summary
A Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.
Interventions
DRUGBGM0504 tablets
Administered p.o.
DRUGPlacebo tablets
Administered p.o.
Sponsors
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female; * Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI \< 28 kg/m²（BMI = weight/height²）; * Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI \< 28.0 kg/m²; * (Medical Inquiry) Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening. * Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study. * Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional medically acceptable form of contraception (female partner) for the duration of the study and for at least 3 months after dosing; must also agree to refrain from sperm donation for at least 3 months post dose
Exclusion criteria
* Those with a history of severe drug allergies (especially those with known or suspected allergies to the active ingredients and excipients of BGM0504 Tablets), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution. * Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period. * At the screening/baseline period, any one of the laboratory test indicators meets the following criteria: 1. fasting serum glucose≥ 7.0mmol/L, or post-prandial glucose (PPG)-2h≥ 11.1mmol/L in oral glucose tolerance test (OGTT); (During screening, participants with fasting serum glucose ranging from 6.1 to 6.9mmol/L shall undergo the OGTT.) 2. ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN) 3. Glomerular filtration rate (eGFR) ≤ 80 mL/min/1.73 m2(using CKD-EPI formula) or positive urine protein 2+ or more. 4. Serum calcitonin level ≥ 35 ng/L (pg/mL); 5. Thyroid-stimulating hormone (TSH) \> 6.0mIU/L or \< 0.4mIU/L; 6. Fasting triglycerides ≥ 5.64mmol/L (500 mg/dL); 7. Hemoglobin (Hgb) \< 100 g/L (for females) or \< 110 g/L (for males); * 12-lead ECG shows ventricular heart rate \< 50 beats/min or \> 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF\> 470ms for women or \> 450ms for men, pre-excitation syndrome or other significant arrhythmias. * Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening. * Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening. * Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial. * Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period. * Positive urine drug test or alcohol serum test result at screening or at baseline. * Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment adverse events | 8 weeks | The relationship of each adverse event to the investigational product was assessed by the investigator |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoint: Concentration of BGM0504 in plasma | 8 weeks |
| Change in fasting weight at week 8 | 8 weeks |
Countries
China
Contacts
Primary ContactJianchang He
Outcome results
None listed