NCT07239973招募中1 期
A Phase 1, 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.
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of treatment adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
- •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.)
- •ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN)
- •Glomerular filtration rate (eGFR) ≤ 80 mL/min/1.73 m2(using CKD-EPI formula) or positive urine protein 2+ or more.
- •Serum calcitonin level ≥ 35 ng/L (pg/mL);
- •Thyroid-stimulating hormone (TSH) > 6.0mIU/L or < 0.4mIU/L;
- •Fasting triglycerides ≥ 5.64mmol/L (500 mg/dL);
- •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.
研究组 & 干预措施
BGM0504 tablets
Experimental
Oral administration once daily
干预措施: BGM0504 tablets (Drug)
Placebo tablets
Experimental
Placebo Oral administration once daily
干预措施: Placebo tablets (Drug)
结局指标
主要结局
Number of treatment adverse events
时间窗: 8 weeks
The relationship of each adverse event to the investigational product was assessed by the investigator
次要结局
- Change in fasting weight at week 8(8 weeks)
- Pharmacokinetic endpoint: Concentration of BGM0504 in plasma(8 weeks)
研究者
研究点 (1)
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