Single and multiple doses study of DS-5565 in healthy Chinese subjects
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT1080223624
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
DS-5565 was safe and well-tolerated at single doses of 5 mg to 15 mg and at multiple doses of up to 15 mg in healthy Chinese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
1)Healthy Chinese
2)Aged 18 years to 45 years (inclusive), at the time of informed consent
3)Body weight of female >= 45 kg, male >= 50 kg, and a BMI in the range of 19.0 kg/m2 to 26.0 kg/m2 (inclusive) at screening
Exclusion Criteria
1)Hypersensitivity or idiosyncratic reactions to a drug (such as penicillin allergy)
2)Presence or history of any drug abuse or of alcohol abuse etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>Safety and pharmacokinetics
- Secondary Outcome Measures
Name Time Method