Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia

Phase 1

Recruiting

• Conditions: Hyperuricemia; Gout
• Interventions: Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

• Registration Number: NCT06629376
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

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。

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-20
• Study First Submitted: 2024-09-06
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-04-20
• Study Completion: 2025-08-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental： group1	Pegylated Recombinant Candida Utilis Uricase for Injection	injection；strength；4mg
Experimental： group2	Pegylated Recombinant Candida Utilis Uricase for Injection	injection；strength；8mg
Experimental： group3	Pegylated Recombinant Candida Utilis Uricase for Injection	injection；strength；12mg
Experimental： group4	Pegylated Recombinant Candida Utilis Uricase for Injection	injection；strength；16mg
Placebo control group	Pegylated Recombinant Candida Utilis Uricase for Injection	The same volume of placebo as SSS11
Experimental： group5	Pegylated Recombinant Candida Utilis Uricase for Injection	injection；strength；20mg

Primary Outcome Measures

Name	Time	Method
The primary outcome was safety.	up to 12 weeks	Assessment AEs by frequency and severity

Secondary Outcome Measures

Name	Time	Method
Difference between post administration blood uric acid and baseline	up to 12 weeks
Duration of blood uric acid<360 μ mol/L	up to 12 weeks
Proportion of subjects with blood uric acid levels below 360 μ mol/L at each sample collection time point	up to 12 weeks

Trial Locations

Locations (1)

HuaShan Hospital Fudan University project, ShangHai, China; 🇨🇳 Shanghai, China