A Phase 1, Single-ascending-dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382
研究概览
简要总结
A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.
详细描述
This is a first-time-in-humans (FTIH), randomized, double-blind study designed to evaluate the safety, tolerability, and PK of MEDI0382 administered as single-ascending SC doses to healthy subjects (age 18-45). Eight subjects per cohort will be enrolled in a total of 8 cohorts. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee (DEC). Within each cohort, the subjects will be randomized to MEDI0382 or placebo (3:1). Following screening, the study duration for each subject will be approximately 29 days, consisting of an inpatient evaluation period, and an outpatient follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers, ages 18-45
- •Must provide written informed consent
- •BMI >22 and <30 kg/m2 and body weight >70kg
- •Venous access suitable for multiple cannulations
- •Vital signs within normal specified ranges
- •Females must be non-lactating and non-childbearing potential
- •Males must practice 2 effective contraceptive measures if sexually active
排除标准
- •Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- •History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- •History of cancer, with the exception of non-melanoma skin cancer
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
- •Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
- •Concurrent or previous use of a GLP-1 receptor agonist
- •Current or previous use of systemic corticosteroids within the past 28 days prior to screening
- •Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
- •Known or suspected history of alcohol or drug abuse within the past 3 years.
- •Positive drug screen
- •Current smoker
研究组 & 干预措施
Placebo
Placebo administered subcutaneously
干预措施: Placebo (Drug)
MEDI0382
MEDI0382 administered subcutaneously
干预措施: MEDI0382 (Drug)
结局指标
主要结局
Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382
时间窗: 28 days post dosing
Treatment emergent adverse events (TEAEs) and serious adverse events (STEAEs)
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
时间窗: 28 days post dosing
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
次要结局
- Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)(72 hours postdose)
- Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)(72 hours post dose)
- Proportion of subjects with ADA to MEDI0382(28 days post dose)