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

Shenyang Sunshine Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Hyperuricemia; Gout

Treatments: Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06629376

SYSS-SSS11-UND-I-03

Details and patient eligibility

About

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。

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)。

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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60 participants in 6 patient groups, including a placebo group

Experimental： group1

Experimental group

Description:

injection；strength；4mg

Treatment:

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Experimental： group2

Experimental group

Description:

injection；strength；8mg

Treatment:

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Experimental： group3

Experimental group

Description:

injection；strength；12mg

Treatment:

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Experimental： group4

Experimental group

Description:

injection；strength；16mg

Treatment:

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Experimental： group5

Experimental group

Description:

injection；strength；20mg

Treatment:

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Placebo control group

Placebo Comparator group

Description:

The same volume of placebo as SSS11

Treatment:

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection