NCT01524406终止1 期
A Randomized, Double-blind, Placebo Controlled, Phase I Study to Evaluate the Safety and Tolerability of 28 Day Treatment With HPP593 Capsules in Healthy Volunteers During and After Limb Immobilization
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety Evaluation
研究概览
简要总结
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking.
- •Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results.
- •Not restricted to a wheel-chair or confined to a bed.
- •Weight ≥ 50.0 kg.
- •BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening.
排除标准
- •Any of the following abnormalities at Screening Visit and Baseline:
- •Fasting glucose > 110 mg/dL (Screening visit only).
- •Serum creatinine > 1.5 mg/dL. If serum creatinine is >1.5 mg/dL and creatinine clearance is >60 mL/min, the subject need not be excluded
- •Troponin I level above the upper limit of normal (ULN)
- •Liver function tests (LFTs) > 1.5x ULN
- •Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension)
- •Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit.
- •Has received HPP593 in a previous clinical trial.
- •Smoking within 6 month prior to Day -
- •Michigan Alcohol Screening Test score greater than 2.
研究组 & 干预措施
HPP593
Experimental
干预措施: HPP593 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety Evaluation
时间窗: Baseline to Day 42
Number and severity of adverse events across trial period
次要结局
- Changes on Muscle Related Biomarkers(Day 1 to Day 29)
- Change in Muscle Strength(Day 1 to Day 42)
研究者
研究点 (1)
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