NCT07382908招募中1 期
A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years (inclusive).
- •Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI < 28.0 kg/m²) or obese (BMI ≥ 28.0 kg/m²).
- •From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm/egg donation.
- •The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.
排除标准
- •History of severe allergies or severe specific allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.
- •Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.
- •Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.
- •History of acute/chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
- •Past or screening findings of digestive system diseases that may increase participant risk.
- •Positive for HBsAg, HCV antibody, syphilis antibody, or HIV antibody at screening.
- •Participation in any drug or medical device clinical trial and receiving investigational product/device intervention within 3 months prior to screening.
- •Consumption or plan to consume specific foods (including pitaya, mango, grapefruit, pomelo or their juices, high-purine foods like animal organs, seafood, chocolate) or beverages containing caffeine/alcohol within 48 hours before dosing; or unwilling to stop consuming these during the in-house period.
- •Pregnant or breastfeeding women, or positive pregnancy test at screening.
- •Any other condition considered by the investigator as unsuitable for participation or participant withdrawal due to personal reasons..
研究组 & 干预措施
Group A
Experimental
干预措施: BGM0504 Injection multi-dose pen (Drug)
Group B
Experimental
干预措施: BGM0504 Injection single-dose pen (Drug)
Group C
Active Comparator
干预措施: BGM0504 Injection single-dose pen (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 0 to 672 hours
Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 0 to 672 hours
Area under the plasma concentration versus time curve (AUC)0-t
次要结局
- Monitor all the adverse event(29 days)
研究者
研究点 (1)
Loading locations...
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