A Phase I, Randomized, Single-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of MOD-6031 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions
研究概览
简要总结
MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The peptide is a natural appetite suppressant, secreted by L-cells in the digestive system following food intake leading to a decrease in gastric emptying, satiety after crossing the blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food intake and increase glycemic control.
详细描述
This will be a a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study. Five escalating dose groups are planned, with 8 subjects per dose group, randomized in 3:1 ratio to receive a single dose of MOD-6031 or matching Placebo (6 MOD-6031 to 2 placebo subjects). The initial MOD-6031 dose will be 20 mg, followed by single doses of 50 mg, 100 mg, 150 mg and 200 mg. Each subject will receive a single study drug injection in the morning (dosing day designated as Day 0) and will be monitored for 30 days.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male, between 18 to 55 years of age.
- •BMI 27-35 Kg/m2 (inclusive).
- •Generally good health.
- •Triglyceride ≤ 400mg/ml
- •ECG with no clinically significant abnormalities.
- •Negative HIV, hepatitis B or hepatitis C serology tests at screening
- •No significant abnormalities in clinical laboratory parameters
- •No history of alcohol or drug abuse.
排除标准
- •History of clinically significant medical condition.
- •Any cardiac conduction defect.
- •Any acute or unstable disease.
- •History of malignancy diagnosed within the past 5 years.
- •Known or suspected diabetes and/or HbA1C >6.4% on screening.
- •Known allergy to any drug.
- •Treatment with weight loss drugs (within 3 months prior to dosing).
- •Liposuction or other surgery for weight loss within the last year.
- •Evidence of eating disorders (bulimia, binge eating).
- •History of regular alcohol consumption exceeding.
- •Use of tobacco or nicotine-containing products.
- •Subjects that have difficulty fasting or consuming the standard meals that will be provided.
研究组 & 干预措施
Dose Cohort 1
20mg MOD-6031 / Placebo
干预措施: MOD-6031 (Drug)
Dose Cohort 1
20mg MOD-6031 / Placebo
干预措施: Placebo control (Other)
Dose Cohort 2
50mg MOD-6031 / Placebo
干预措施: MOD-6031 (Drug)
Dose Cohort 2
50mg MOD-6031 / Placebo
干预措施: Placebo control (Other)
Dose Cohort 3
100mg MOD-6031 / Placebo
干预措施: MOD-6031 (Drug)
Dose Cohort 3
100mg MOD-6031 / Placebo
干预措施: Placebo control (Other)
Dose Cohort 4
150mg MOD-6031 / Placebo
干预措施: MOD-6031 (Drug)
Dose Cohort 4
150mg MOD-6031 / Placebo
干预措施: Placebo control (Other)
Dose Cohort 5
200mg MOD-6031 / Placebo
干预措施: MOD-6031 (Drug)
Dose Cohort 5
200mg MOD-6031 / Placebo
干预措施: Placebo control (Other)
结局指标
主要结局
Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions
时间窗: 30 days
次要结局
- Vz/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)(0 to 30 days)
- Elimination rate constant of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)(0 to 30 days)
- CL/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)(0 to 30 days)
- Cmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)(0 to 30 days)
- Tmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)(0 to 30 days)
- AUC(0-t) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)(0 to 30 days)
- AUC(inf) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)(0 to 30 days)
- T(½) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)(0 to 30 days)