drugset / Trial / NCT05588908
A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the target dose of phase II and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-IL-1β humanized monoclonal antibody injection at different doses in Chinese participants with acute gout.
Timeline
- Start
- 2022-06-29
- Primary completion
- 2023-09
- Completion
- 2023-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BETAMETHASONE DIPROPIONATE | Small molecule | 1 ml | Intramuscular |
| Subject | SSGJ-613 | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | SSGJ-613 | Monoclonal antibody | 200 mg | Subcutaneous |
| Subject | SSGJ-613 | Monoclonal antibody | 300 mg | Subcutaneous |