NCT06972992已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection, for Subcutaneous Use in Combination With Semaglutide in Participants With Obesity
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject have provided informed consent before initiation of any study specific procedures
- •Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
- •No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, e.g., Clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the Investigator (or sub-I).
- •Stable body weight (less than 5% self-reported change within the previous 3 months)
排除标准
- •Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
- •Have a history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- •Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year.
- •Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- •Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.
研究组 & 干预措施
Combo Cohort 1 in participants with obesity
Experimental
Cohort 1, dose 1
干预措施: ASC47 +Semaglutide (Drug)
Combo Cohort 1 in participants with obesity
Experimental
Cohort 1, dose 1
干预措施: Placebo+Semaglutide (Drug)
Combo Cohort 2 in participants with obesity
Experimental
Cohort 2, dose 2
干预措施: ASC47 +Semaglutide (Drug)
Combo Cohort 2 in participants with obesity
Experimental
Cohort 2, dose 2
干预措施: Placebo+Semaglutide (Drug)
Combo Cohort 3 in participants with obesity
Experimental
Cohort 3, dose 3
干预措施: ASC47 +Semaglutide (Drug)
Combo Cohort 3 in participants with obesity
Experimental
Cohort 3, dose 3
干预措施: Placebo+Semaglutide (Drug)
结局指标
主要结局
Adverse events
时间窗: up to 71 days
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
次要结局
- Change From Baseline in Body Weight(up to 71 days)
- Cmax of ASC47(up to 71 days)
- AUC of ASC47(up to 71 days)
- T1/2 of ASC47(up to 71 days)
- CL/F of ASC47(up to 71 days)
研究者
研究点 (1)
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