A phase I clinical study of KSP-0243
Phase 1
- Conditions
- Healthy Condition
- Registration Number
- JPRN-jRCT2071200087
- Lead Sponsor
- Shimizu Yoshitaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 144
Inclusion Criteria
BMI: Between 18.5 kg/m^2 or greater and less than 25 kg/m^2 in Japanese, between 18.5 kg/m^2 or greater and less than 30 kg/m^2 in Caucasian.
Exclusion Criteria
Participants with any abnormal findings (e.g. clinical laboratory test values outside the reference range) during the physical examination and other tests (vital signs, 12-lead ECG and clinical laboratory tests) that are judged by investigators to be clinically significant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event
- Secondary Outcome Measures
Name Time Method Adverse drug reaction<br>Vital sign<br>12-lead ECG<br>Laboratory test<br>Plasma pharmacokinetics profile<br>Urine excretion profile