A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection
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
- •Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site.
- •Are between 18 and 65 years of age (both inclusive) at time of screening.
- •No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
排除标准
- •Have evidence of any clinically significant active or chronic disease.
- •Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
- •Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- •Have a history of acute or chronic pancreatitis.
- •Have a known clinically significant gastric emptying abnormality.
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
- •Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
研究组 & 干预措施
SAD Cohort 1
SAD Dose 1
干预措施: ASC35 Injection B, for subcutaneous use (Drug)
SAD Cohort 1
SAD Dose 1
干预措施: ASC35 Placebo Injection B, for subcutaneous use (Drug)
SAD Cohort 2
SAD Dose 2
干预措施: ASC35 Injection B, for subcutaneous use (Drug)
SAD Cohort 2
SAD Dose 2
干预措施: ASC35 Placebo Injection B, for subcutaneous use (Drug)
SAD Cohort 3
SAD Dose 3
干预措施: ASC35 Injection B, for subcutaneous use (Drug)
SAD Cohort 3
SAD Dose 3
干预措施: ASC35 Placebo Injection B, for subcutaneous use (Drug)
SAD Cohort 4
SAD Dose 4
干预措施: ASC35 Injection B, for subcutaneous use (Drug)
SAD Cohort 4
SAD Dose 4
干预措施: ASC35 Placebo Injection B, for subcutaneous use (Drug)
MAD Cohort 1
MAD Cohort 1
干预措施: ASC35 Injection B, for subcutaneous use (Drug)
MAD Cohort 1
MAD Cohort 1
干预措施: ASC35 Placebo Injection B, for subcutaneous use (Drug)
MAD Cohort 2
MAD Cohort 2
干预措施: ASC35 Injection B, for subcutaneous use (Drug)
MAD Cohort 2
MAD Cohort 2
干预措施: ASC35 Placebo Injection B, for subcutaneous use (Drug)
MAD Cohort 3
MAD Cohort 3
干预措施: ASC35 Injection B, for subcutaneous use (Drug)
MAD Cohort 3
MAD Cohort 3
干预措施: ASC35 Placebo Injection B, for subcutaneous use (Drug)
MAD Cohort 4
MAD Cohort 4
干预措施: ASC35 Injection B, for subcutaneous use (Drug)
MAD Cohort 4
MAD Cohort 4
干预措施: ASC35 Placebo Injection B, for subcutaneous use (Drug)
MAD Cohort 0
MAD Cohort 0
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Adverse events
时间窗: Baseline and Day 141
A summary of AEs, SAEs and other non-serious adverse events
次要结局
- Cmax of ASC35(Baseline and Day 141)
- Tmax of ASC35(Baseline and Day 141)
- AUC of ASC35(Baseline and Day 141)
- Change From Baseline in Body Weight(Baseline and Day 141)