A randomized, double-blind, placebo-controlled, continuous IV infusion for 96 hours, ascending dose study to assess the safety, pharmacokinetics and pharmacodynamics of CS-4771 in Japanese healthy subjects
- Conditions
- Healthy male volunteers
- Registration Number
- JPRN-jRCT2080221894
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 24
male Japanese
- between the age of 20 and 45
- between the BMI of 18.5 and 25.0
- A history of serious diseases caused by disorders of the central nervous system, circulatory system, respiratory system, blood/hematopoietic system, gastrointestinal system, hepatic and renal function, thyroid function, pituitary gland function, adrenal function, etc., and the judgment of the investigator or subinvestigator that participation in the clinical study could pose a risk to the subject's safety
- MetHB level of 2% or greater, or MetHB value of 0.24 g/dL or greater
- Hypersensitivity to methylene blue or Toll-like receptor 4 (TLR4) inhibitors
- Inappropriateness for inclusion into the study as judged by the investigator or subinvestigator (for example, subjects who may have difficulty in visiting the study center or ensuring compliance)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Pharmacodynamic and Pharmacokinetic
- Secondary Outcome Measures
Name Time Method To evaluate safety endpoints according to the adverse events, vital signs, 12-lead ECGs and laboratory values.<br>To evaluate pharmacodynamic endpoints according to the release of TNF-a and IL-6 when whole blood is stimulated ex vivo using LPS.<br>To evaluate pharmacokinetic endpoints according to the free form of CS 4771 in plasma.