drugset / Trial / NCT02934412
A Study of SHR-1314 in Healthy Subjects
RandomizedParallel-groupTriple-blindOther
Summary
This is a randomized, double-blind, placebo-controlled, single dose escalating, study in 5 sequential cohorts to investigate the effect of a single s.c. injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects. Each cohort will consist of 6 subjects receiving active drug and 2 subjects receiving placebo, for a total of approximately 40 subjects dosed at one study site.
Timeline
- Start
- 2016-08-22
- Primary completion
- 2017-06-30
- Completion
- 2017-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vunakizumab | Protein / enzyme biologic | 20 mg | Subcutaneous |
| Subject | vunakizumab | Protein / enzyme biologic | 40 mg | Subcutaneous |
| Subject | vunakizumab | Protein / enzyme biologic | 80 mg | Subcutaneous |
| Subject | vunakizumab | Protein / enzyme biologic | 160 mg | Subcutaneous |
| Subject | vunakizumab | Protein / enzyme biologic | 240 mg | Subcutaneous |