A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and Drug Drug Interaction of MBX 1416 in healthy volunteers
This study includes 3 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part C involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of MBX 1416.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind
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
- •Female and male adults, ages ≥ 18 and ≤ 65 years with a body mass index (BMI) ≥ 18 kg/m² to ≤ 30.0 kg/m² and fasting glucose < 100 mg/dL and HbA1c < 5.7%.
- •Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.
排除标准
- •Pregnant, lactating or intending to become pregnant during the study.
- •Use of weight-lowering pharmacotherapy or participation in a clinical weight control study within the previous 3 months prior to the first dose of study drug.
- •Presence of clinically significant ECG findings
- •Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
- •Abnormal laboratory results at Screening.
- •History of renal disease or abnormal kidney function tests at Screening
- •Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.
研究组 & 干预措施
MBX 1416 (Part A)
Single ascending subcutaneous (SC) doses
干预措施: MBX 1416 (Part A) (Drug)
MBX 1416 (Part B)
Repeated ascending subcutaneous (SC) doses
干预措施: MBX 1416 (Part B) (Drug)
Placebo
干预措施: Placebo (Drug)
MBX 1416 (Part C)
Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.
干预措施: MBX 1416 (Part C) (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)
时间窗: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
次要结局
未报告次要终点