DS-6016a Phase I Study- Single ascending dose study to assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese subjects.
Phase 1
- Conditions
- Fibrodysplasia ossificans progressiva
- Registration Number
- JPRN-jRCT2051200155
- Lead Sponsor
- Inoguchi Akihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 48
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:<br>Adverse Events, laboratory data, body weight, vital signs, and 12-lead Electrocardiography
- Secondary Outcome Measures
Name Time Method -Plasma pharmacokinetics parameters for DS-6016a<br> -Formation of anti-drug antibody and anti-host cell protein antibody