JPRN-UMIN000019104已完成未知
Randomized, placebo-controlled Phase I study of SJP-0008 in healthy adult volunteers (single and repeated dose study) - Phase I study of SJP-0008 in healthy adult volunteers
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 35years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •1) History of serious disease (e.g.: eye, liver, kidney, cardiac, digestive or blood disease) 2) Subjects with cardiac disease including cardiac failure and ischemic heart disease. 3) Subjects with QTc interval of 450 ms or greater. 4) Subjects with notable respiratory arrhythmia, frequent premature beat or branch block. 5) Subjects with abnormal of serum electrolyte levels. 6) Subjects with eGFR of under 60 mL/min/1.73 m^2. 7) Subjects with exceed reference level of AST or ALT. 8) History of drug allergy. 9) Use of any drugs (including over the counter drugs) within past 2 week. 10) Subjects with donation of blood more than 400 mL within past 3 months. 11) Participation in any other clinical study within past 4 months. 12) History of keratorefractive surgery or traumatic injury of any eyes. 13) Willing to use contact lens during the study. 14) Subject with best-corrected visual acuity equal to or less than 1.0. 15) Subject with BMI less than 18.5 or more than 25.0. 16) Subjects do not agree with contraception or correspondence to partner's pregnancy.
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