Trials / Unknown
UnknownNCT02423538
First-in-Human Single Ascending Dose of SHR0302
A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR0302 | Oral tablets (1 mg, 5 mg, 10 mg) |
| DRUG | SHR0302 placebo comparator | Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication) |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-07-01
- First posted
- 2015-04-22
- Last updated
- 2016-01-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02423538. Inclusion in this directory is not an endorsement.