NCT07224399招募中1 期
A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
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 treatment adverse events
研究概览
简要总结
This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy 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
- •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.
- •Body mass index (BMI) meeting one of the following requirements:
- •Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese) (for Cohort 3-6); OR
- •Between ≥ 27.0 kg/m2 and < 30.0 kg/m2 (overweight) with at least 1 of the following: One or more symptoms of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia (For Cohort 3- 6); OR
- •Between ≥ 23.0 kg/m2 and < 27.0 kg/m2 healthy subjects (for Cohort 1 and Cohort 2)
- •Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening
排除标准
- •Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to amylin agonist-based therapeutic agents or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
- •Known type I/II diabetes.
- •Has underwent gastric bariatric surgery in the past, or has had liposuction or fat removal within 1 year before screening, or plan to have bariatric surgery, liposuction or abdominal fat removal during the study period or other surgery that would obviously affect the body weight.
- •History of acute or chronic pancreatitis or pancreatic injury.
- •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 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)
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)
结局指标
主要结局
Number of treatment adverse events
时间窗: Predose up to 6 weeks (Part A) & 9 weeks (Part B)
The relationship of each adverse event to the investigational product was assessed by the investigator
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of BGM1812(Predose through week 6 (Part A) & week 9 (Part B))
- PK: Maximum Observed Concentration (Cmax) of BGM1812(Predose through week 6 (Part A) & week 9 (Part B))
- Pharmacodynamics (PD): Change from baseline in fasting body weight(Predose through week 6 (Part A) & week 9 (Part B))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy VolunteersPulmonary Arterial HypertensionNCT04505137Gmax Biopharm Australia Pty Ltd.16
已完成
1 期
A Trial of SHR-1905 in Healthy SubjectsAsthmaNCT04800263Atridia Pty Ltd.50
终止
1 期
A Trial of SHR-1703 in Healthy SubjectsAsthmaNCT04855591Atridia Pty Ltd.1
已完成
1 期
Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy AdultsHealthy VolunteersNCT04005807Belite Bio, Inc40
已完成
1 期
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy VolunteersHealthyNCT04527718Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.40