NCT06629376 Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
| NCT ID | NCT06629376 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. |
| Condition | Gout |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-11-20 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2023-11-20 with a primary completion date of 2026-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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。
Eligibility Criteria
Inclusion Criteria: * A patient with clinical diagnosis of gout (according to the 2015 ACR/EULAR gout classification criteria), non acute attack phase, and hyperuricemia {under normal purine diet, blood uric acid\>420 µ mol/L (7 mg/dl) not tested twice on an empty stomach on the same day}。 * Screening period blood uric acid\>420 µ mol/L (7mg/dl)。 Exclusion Criteria: * Within 14 days prior to enrollment (or within 5 half lives of the drug, whichever is longer), medication that lowers uric acid levels or affects uric acid levels and related drugs (allopurinol, febuxostat, benzbromarone, probenecid, benzenesulfonazolone, Tongyifengning tablets, etc.) must be taken, or during the study period, other drugs that lower uric acid levels or affect uric acid levels and related drugs other than experimental drugs must not be discontinued。 * Patients with acute gout attacks within 14 days prior to enrollment。 * Previously received uric acid oxidase or treated with similar drugs such as pegolase or rabulidase。 * Individuals with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD enzyme activity levels below the lower limit of normal。 * Individuals with a history of catalase deficiency or evidence that meets the diagnostic criteria for catalase deficiency。 * Malignant tumor patients (whether treated or not)。
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06629376 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Gout. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06629376 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06629376 currently recruiting?
Yes, NCT06629376 is actively recruiting participants. Contact the research team at mail@hjzou.com/zhangj_fudan@163.com for enrollment information.
Where is the NCT06629376 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06629376 clinical trial?
NCT06629376 is sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. The trial plans to enroll 60 participants.