Randomized, placebo-controlled Phase I study of SJP-0008 in healthy adult volunteers (single and repeated dose study)
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000019104
- Lead Sponsor
- Senju Pharmaceutical co.,ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 90
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation (Clinical examination, Vital sign, Ophthalmic examination, Laboratory test, Adverse event) and Pharmacokinetics of SJP-0008
- Secondary Outcome Measures
Name Time Method