A PHASE I, TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS
Phase 1
- Conditions
- Healthy Volunteer
- Registration Number
- JPRN-jRCT2071220036
- Lead Sponsor
- Kai Megumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Signed ICF
- Able to comply with the study protocol, in the investigators judgment
- BMI at screening: (Body weight [kg]/height [m]2) =>18.5 to <25.0
- Absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination, vital signs, 12-lead ECG, and laboratory tests
Exclusion Criteria
- Clinically significant ECG abnormalities at screening
- known congenital arrhythmiarespiratory, circulatory, endocrine, hematological, gastrointestinal, immune, psychological/nervous system, renal, hepatic, or allergic disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>Frequency, severity and causal reletionship of AE and SAE with RAY121<br>Changes in Lab value,Vital, and ECG parameters from Baseline
- Secondary Outcome Measures
Name Time Method Phamacokinetics, Phamacodynamics