Safety and pharmacokinetics of nebulized CS-8958
Phase 1
Completed
- Conditions
- healthy volunteers
- Registration Number
- JPRN-jRCT2080222944
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
After a single inhaled administration of CS-8958 40 to 320 mg, plasma concentrations of CS-8958 and laninamivir increased almost dose proportionally. After a single inhaled administration of CS-8958 160 mg, laninamivir was retained in the trachea and lungs over long periods, and these PK profiles support its long-lasting effect against influenza virus infection. A single administration of 40 to 320 mg of CS-8958 inhaled using a nebulizer was no safety concern and well tolerated in healthy adult subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 64
Inclusion Criteria
1) male Japanese
2) between the age of 20 and 45
3) between the BMI of 18.5 and 25.0
Exclusion Criteria
1) Subjects with abnormal lung function tests will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method