NCT07294235招募中1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator
研究概览
简要总结
The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.
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 < 24 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 related compounds of BGM1812), 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.
- •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
BGM1812 (Part B)
Experimental
Multiple ascending doses of BGM1812 administered SC.
干预措施: BGM1812 (Drug)
Placebo (Part B)
Placebo Comparator
Placebo administered SC.
干预措施: Placebo (Drug)
BGM1812(Part A)
Experimental
Single ascending doses of BGM1812 administered subcutaneously (SC)
干预措施: BGM1812 (Drug)
Placebo (Part A)
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator
时间窗: Baseline to Study Completion (Up to 6-9weeks)
Number of participants with AEs and SAEs will be assessed with reference to CTCAE V5.0
次要结局
- Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812(Baseline to Study Completion (Up to 6-9weeks))
- PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812(Baseline to Study Completion (Up to 6-9weeks))
- Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812(Baseline to Study Completion (Up to 6-9weeks))
- PD:C-Peptide of BGM1812(Baseline to Study Completion (Up to 6-9weeks))
- PD: Insulin of BGM1812(Baseline to Study Completion (Up to 6-9weeks))
- PD: Body Weight of BGM1812(Baseline to Study Completion (Up to 6-9weeks))
- PD: Waist Circumference of BGM1812(Baseline to Study Completion (Up to 6-9weeks))
- Immunogenicity Endpoints(Baseline to Study Completion (Up to 6-9weeks))
研究者
研究点 (1)
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