drugset / Trial / NCT06629376
Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.The main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase (test drug code: SSS11) in patients with gout and hyperuricemia.The experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。
Timeline
- Start
- 2023-11-20
- Primary completion
- 2026-12-20
- Completion
- 2027-08-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegylated Recombinant Candida Utilis Uricase | Protein / enzyme biologic | 4 mg | Intravenous |
| Subject | Pegylated Recombinant Candida Utilis Uricase | Protein / enzyme biologic | 8 mg | Intravenous |
| Subject | Pegylated Recombinant Candida Utilis Uricase | Protein / enzyme biologic | 12 mg | Intravenous |
| Subject | Pegylated Recombinant Candida Utilis Uricase | Protein / enzyme biologic | 16 mg | Intravenous |
| Subject | Pegylated Recombinant Candida Utilis Uricase | Protein / enzyme biologic | 20 mg | Intravenous |