A PHASE I, TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS

JRCT ID: jRCT2071220036

Registered date:04/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy Volunteer
• Date of first enrollment: 24/10/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): RAY121: RAY121 is administered as a intravenously or subcutaneously at the prescribed dose.

Outcome(s)

Primary Outcome

Safety
Frequency, severity and causal reletionship of AE and SAE with RAY121
Changes in Lab value,Vital, and ECG parameters from Baseline

• Secondary Outcome: Phamacokinetics, Phamacodynamics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 44age old
• Gender: Both

Include 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

Exclude criteria

- Clinically significant ECG abnormalities at screening
- known congenital arrhythmiarespiratory, circulatory, endocrine, hematological, gastrointestinal, immune, psychological/nervous system, renal, hepatic, or allergic disorder

Related Information

• Primary Sponsor: Kai Megumi