drugset / Trial / NCT02673593
Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
RandomizedParallel-groupTriple-blind
Summary
The purpose of the study is to investigate the safety, pharmacokinetics and food effect of DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants. DS102 capsules will be orally administered for up to 4 weeks, and will be compared against placebo. The study will enrol approximately 56 adult subjects.
Timeline
- Start
- 2015-07
- Primary completion
- 2015-12
- Completion
- 2015-12
Outcome
Met primary endpoint
release “DS102 was safe and well tolerated, thereby successfully meeting the study’s primary safety objective.” afimmune.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DS102 | Unknown | 100 mg | Oral |
| Subject | DS102 | Unknown | 500 mg | Oral |
| Subject | DS102 | Unknown | 1000 mg | Oral |
| Subject | DS102 | Unknown | 2000 mg | Oral |
Indications
No indication recorded.