A Phase 1, single-dose and multiple-dose study of DS-2319b inhalation powder to assess the safety and pharmacokinetics of DS-2319a in healthy Japanese subjects
Phase 1
- Conditions
- SARS-CoV-2 Infectious Disease
- Registration Number
- JPRN-jRCT2051200153
- Lead Sponsor
- Inoguchi Akihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 76
Inclusion Criteria
1. Japanese healthy male subjects.
2. Age >=20 and <=45 years upon providing informed consent.
3. Body mass index (BMI) >=18.5 and <25.0 kg/m2 at screening.
Exclusion Criteria
1. Having a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy)
2. Having alcohol or drug dependence etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety:AEs, laboratory data, body weight, vital signs, 12-lead ECGs, and chest X-ray
- Secondary Outcome Measures
Name Time Method PK:Concentration of plasma DS-2319a and PK parameters for plasma DS-2319a