Single Ascending-dose Study of Injectable Favipiravir

Phase 1

• Conditions: severe fever with thrombocytopenia syndrome

• Registration Number: JPRN-jRCT2071210042
• Lead Sponsor: Sakurai Tsutomu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

(1) Subjects between 20 and 39 years of age (inclusive) at informed consent
(2) Gender: Male subjects
(3) Subjects with BMI in the range of 18.5 or more and less than 30.0 kg/m2 and body weight 55 kg or more
(4) Subjects who understand the objectives of the study, volunteer to participate in the study, and are able to provide written informed consent

Exclusion Criteria

(1) Subjects with a medical history of gastrointestinal, skin, renal, hepatic, neurological, hematological, endocrine, cancer, respiratory, immunological, psychological, cardiovascular, or other diseases that is considered to affect safety of the subjects and evaluation of the study drug by the principal investigator or subinvestigator
(2) Subjects with a history of surgery or a disease condition that is considered by the principal investigator or subinvestigator to affect the distribution, metabolism, and excretion of the study drug
(3) Subjects who have previously received favipiravir
(4) Subjects who are deemed to be ineligible for the study by the principal investigator or subinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified