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

May 26, 2025 updated by: Shenyang Sunshine Pharmaceutical Co., LTD.

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

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。

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • HuaShan Hospital Fudan University project, ShangHai, China
        • Contact:
          • hejian zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental： group1
injection；strength；4mg
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
Other Names:
  • SSS11
Experimental: Experimental： group2
injection；strength；8mg
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
Other Names:
  • SSS11
Experimental: Experimental： group3
injection；strength；12mg
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
Other Names:
  • SSS11
Experimental: Experimental： group4
injection；strength；16mg
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
Other Names:
  • SSS11
Experimental: Experimental： group5
injection；strength；20mg
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
Other Names:
  • SSS11
Placebo Comparator: Placebo control group
The same volume of placebo as SSS11
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
Other Names:
  • SSS11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome was safety.
Time Frame: up to 12 weeks
Assessment AEs by frequency and severity
up to 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

August 8, 2027

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSS-SSS11-UND-I-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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