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

NCT06629376 | Recruiting Phase 1

• 1 other identifier: SYSS-SSS11-UND-I-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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。

Conditions

Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• The primary outcome was safety.

  Assessment AEs by frequency and severity

  up to 12 weeks

Secondary Outcomes (3)

• 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

Study Arms (6)

Experimental： group1

EXPERIMENTAL

injection；strength；4mg

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Experimental： group2

EXPERIMENTAL

injection；strength；8mg

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Experimental： group3

EXPERIMENTAL

injection；strength；12mg

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Experimental： group4

EXPERIMENTAL

injection；strength；16mg

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Experimental： group5

EXPERIMENTAL

injection；strength；20mg

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Placebo control group

PLACEBO COMPARATOR

The same volume of placebo as SSS11

Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Interventions

Pegylated Recombinant Candida Utilis Uricase for Injection DRUG

According to the dosage requirements of each experimental group, intravenous infusion should be administered for at least 2 hours each time

Also known as: SSS11

Experimental： group1; Experimental： group2; Experimental： group3; Experimental： group4; Experimental： group5; Placebo control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)。

You may not qualify if:

• 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)。

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

HuaShan Hospital Fudan University project, ShangHai, China

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

Injections

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

hejian zou, professor

CONTACT

021-52889999; mail@hjzou.com/zhangj_fudan@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: October 8, 2024
• Study Start: November 20, 2023
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): August 8, 2027
• Last Updated: May 28, 2025

Record last verified: 2024-10

Locations

CN (1)