drugset / Trial / NCT02603185
PhaseⅠFirst-in-Human Study of Hemay007 in Healthy Volunteers
Phase 1
Unknown
82 enrolled
Hemay Pharmaceutical PTY. LTD.
Tianjin Hemay Pharmaceutical Co., Ltd · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3, respectively. Food effect following a single oral dose will be evaluated in Part 2.
Timeline
- Start
- 2017-01-09
- Primary completion
- 2018-03
- Completion
- 2018-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hemay007 | Unknown | 0.2 g | Oral |
| Subject | Hemay007 | Unknown | 0.6 g | Oral |
| Subject | Hemay007 | Unknown | 1.2 g | Oral |
| Subject | Hemay007 | Unknown | 2 g | Oral |
| Subject | Hemay007 | Unknown | 3 g | Oral |