Trials / Unknown
UnknownNCT03668509
Safety, Tolerability and PK/PD of SHR1459 in Healthy Volunteers
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR1459, in Healthy Volunteers
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This was a phase I, single-center, double-blind, randomized, placebo-controlled study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of the investigational medicinal product in healthy volunteers.
Detailed description
The study originally planned to enroll 3 cohorts of 10 subjects each (N=30).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR1459 | oral adminstration, single dose |
Timeline
- Start date
- 2018-09-01
- Primary completion
- 2019-01-01
- Completion
- 2019-03-01
- First posted
- 2018-09-12
- Last updated
- 2018-09-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03668509. Inclusion in this directory is not an endorsement.