Trials / Recruiting
RecruitingNCT06629376
Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacological Studies of SSS11 in Patients With Gout and Hyperuricemia After Multiple Administrations, Dose Escalation, Randomized Double-blind, Placebo-controlled Trials
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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。
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pegylated Recombinant Candida Utilis Uricase for Injection | According to the dosage requirements of each experimental group, intravenous infusion should be administered for at least 2 hours each time |
Timeline
- Start date
- 2023-11-20
- Primary completion
- 2026-12-20
- Completion
- 2027-08-08
- First posted
- 2024-10-08
- Last updated
- 2025-05-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06629376. Inclusion in this directory is not an endorsement.