A Phase 1, Combined Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of MEDI4166 in Subjects With Type 2 Diabetes Mellitus (T2D)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 12
- 主要终点
- Part B: Change in LDL-C from baseline to Day 36
研究概览
简要总结
A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).
详细描述
This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and multiple ascending doses to subjects with T2D.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes, ages 18-65
- •Must provide written informed consent
- •BMI>=25 and =<42
- •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 basal cell carcinoma or carcinoma of the cervix
- •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
- •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 weight loss is prohibited.
- •Positive drug screen
- •Type 1 diabetes
研究组 & 干预措施
Placebo
Placebo administered subcutaneously
干预措施: Placebo (Biological)
MEDI-4166
MEDI-4166 administered subcutaneously
干预措施: MEDI-4166 (Biological)
结局指标
主要结局
Part B: Change in LDL-C from baseline to Day 36
时间窗: 36 days post dosing
Part B: Change in LDL-C from baseline to Day 36
Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36
时间窗: 36 days post dosing
Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36
Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166
时间窗: 43 days post dosing
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
次要结局
- Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)(71 days post dosing)
- Part B: Change from baseline in fructosamine levels(36 days post dosing)
- Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166(43 days post dosing)
- Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)(43 days post dosing)
- Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)(71 days post dosing)
- Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)(43 days post dosing)
- Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)(43 days post dosing)
- Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)(71 days post dosing)
- Part A: Change from baseline in LDL-C(43 days post dosing)
- Part B: Proportion of subjects with ADA to MEDI4166(71 days post dosing)
- Part A: Change from baseline in glucose AUC up to 240 minutes(43 days post dosing)
- Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166(71 days post dosing)