STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF REVN24 IN HEALTHY MALE VOLUNTEERS
- Conditions
- Healthy Volunteer
- Registration Number
- JPRN-jRCT2071230074
- Lead Sponsor
- Megumi Kai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 179
Signed ICF.
- Able to comply with the study protocol, in the investigators judgment.
- Have a body mass index (body weight [kg]/height [m]^2) >=18.5 kg/m^2 or <25.0 kg/m^2(Cohorts A-1 to A-9 and B-1 to B-5) or >=18.5 kg/m^2 or <30.0 kg/m^2 (Cohorts A-10 to A13), and body weight >=50 kg at screening.
- Have no findings indicating an active or chronic disease, based on detailed hearing of medical and surgery histories and the results of physical examination, vital sign measurements, ECG, and laboratory tests.
- Clinically significant abnormal ECG at screening.
- Current cardiovascular, renal, hepatic, gastrointestinal, hematologic, immune, neurologic, endocrine, metabolic, or pulmonary disorder or a history of any of these disorders and impaired renal, hepatic, or cardiopulmonary function.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method