Trials / Completed
CompletedNCT03704428
Safety, Tolerability and PK of SHR1314 in axSpA
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.
Detailed description
This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1314 | Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection. |
Timeline
- Start date
- 2018-04-19
- Primary completion
- 2020-01-14
- Completion
- 2020-01-14
- First posted
- 2018-10-12
- Last updated
- 2021-01-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03704428. Inclusion in this directory is not an endorsement.