drugset / Trial / NCT05027373
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects. Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.
Timeline
- Start
- 2021-08-13
- Primary completion
- 2022-04-30
- Completion
- 2022-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SSGJ-613 | Monoclonal antibody | 0.03 mg/kg | Subcutaneous |
| Subject | SSGJ-613 | Monoclonal antibody | 1 mg/kg | Subcutaneous |
| Subject | SSGJ-613 | Monoclonal antibody | 3 mg/kg | Subcutaneous |
| Subject | SSGJ-613 | Monoclonal antibody | 6 mg/kg | Subcutaneous |
| Subject | SSGJ-613 | Monoclonal antibody | 10 mg/kg | Subcutaneous |