drugset / Trial / NCT03710681
A Safety Study of Multiple Subcutaneous (s.c.) Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis. The primary objective of this study is to investigate the safety and tolerability of multiple doses of subcutaneous SHR-1314 in subjects with moderate-to-severe plaque psoriasis. Secondary objectives are to determine the pharmacokinetics (PK) and immunogenicity profile of SHR-1314 in subjects with moderate-to-severe plaque psoriasis.
Timeline
- Start
- 2018-08-02
- Primary completion
- 2019-04-21
- Completion
- 2019-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vunakizumab | Protein / enzyme biologic | 160 mg | Subcutaneous |
| Subject | vunakizumab | Protein / enzyme biologic | 240 mg | Subcutaneous |