A Phase 1 study of S-337395

JRCT ID: jRCT2031230033

Registered date:17/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: RS virus infection
• Date of first enrollment: 14/04/2023
• Target sample size: 83
• Study type: Interventional
• Intervention(s): S-337395 or placebo by oral administration

Outcome(s)

• Primary Outcome: Adverse events, physical examination, laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature), 12 lead ECG, and Holter ECG

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

- Those who aged >=18 to =<55 years, at the time of signing the informed consent form.
- Those who have body mass index of >=18.5 (kg/m2) to =<30.0 (kg/m2).

• Exclude criteria: Considered by the investigator or subinvestigator (suitably qualified) to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, cardiovascular, gastrointestinal or neurological disorders that are considered by the investigator to constitute a safety risk upon the study drug administration or to interfere with the interpretation of data.

Related Information

• Primary Sponsor: Gomez Juan Carlos