NCT00942240已完成1 期
A Phase I, Double-Masked, Multiple Rising Dose Study of ACU-4429 in Healthy Male and Female Subjects
Kubota Vision Inc.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of repeated doses of a new investigational drug (ACU-4429) in healthy human subjects.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males or females, between 25 and 55 years of age, inclusive
- •within BMI range 19 to 32 kg/m2 at Screening
- •in good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs;
- •clinical laboratory evaluations (including serum for Chem-20 [fasted at least 10 hours], CBC with differential and platelet counts, PT, INR, and aPTT, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
- •Males (or female partners of male subjects)and females must be sterile, or agree to use approved contraceptive measures throughout the study period and 45 days after the End of In House Study.
- •able to comprehend and willing to sign an Informed Consent Form.
排除标准
- •significant history or clinical manifestation of any significant metabolic, endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator);
- •history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
- •history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed;
- •history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant;
- •participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in;
- •Is currently using, or has recently received treatment with a medication disallowed by the Protocol.
研究组 & 干预措施
ACU-4429 tablet
Experimental
干预措施: ACU-4429 (Drug)
matching placebo tablet
Placebo Comparator
干预措施: matching placebo tablet (Drug)
结局指标
主要结局
Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests
时间窗: 20 days
次要结局
- Pharmacokinetics as measured by plasma ACU-4429 drug levels(16 days)
研究者
研究点 (1)
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