STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF REVN24 IN HEALTHY MALE VOLUNTEERS

JRCT ID: jRCT2071230074

Registered date:16/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Volunteer
• Date of first enrollment: 26/10/2023
• Target sample size: 179
• Study type: Interventional

Intervention(s)

REVN24: Single and multiple intravenous infusions of REVN24 at the indicated doses.
Placebo (REVN24 Dilution aid): Single and multiple IV infusions of placebo will be administered at the specified doses.

Outcome(s)

Primary Outcome

safety, other
- Frequency, severity and relationship of adverse events including serious adverse events (SAE) to REVN24
- Laboratory values, vital signs and ECGs

• Secondary Outcome: phamacokinetics, phamacodynamics

Key inclusion & exclusion criteria

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

Include criteria

- 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.

Exclude criteria

- 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.

Related Information

• Primary Sponsor: Megumi Kai