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RecruitingNCT06629376Updated May 28, 2025

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

A Phase 1 interventional study of Pegylated Recombinant Candida Utilis Uricase for Injection in Gout and Hyperuricemia, sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD. (part of 3SBio Inc.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Nov 2023, registered Sep 2024).
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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。

02

Conditions studied

  • Gout
  • Hyperuricemia

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03

In context

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

This study's planned enrollment of 60 is below the median of 83 across 286 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD. is the lead sponsor of 40 studies on the registry; 23 are open to participants now.

Browse Shenyang Sunshine Pharmaceutical Co., LTD. studies →All 3SBio Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)。
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental： group1

    injection；strength；4mg

    Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

  • Experimental
    Experimental： group2

    injection；strength；8mg

    Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

  • Experimental
    Experimental： group3

    injection；strength；12mg

    Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

  • Experimental
    Experimental： group4

    injection；strength；16mg

    Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

  • Experimental
    Experimental： group5

    injection；strength；20mg

    Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

  • Placebo comparator
    Placebo control group

    The same volume of placebo as SSS11

    Drug: Pegylated Recombinant Candida Utilis Uricase for Injection

Interventions

  • DrugPegylated 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

    Also known as: SSS11

06

What researchers measure

Primary outcomes

  1. The primary outcome was safety.

    Assessment AEs by frequency and severity

    Time frame: up to 12 weeks

Secondary outcomes

  1. Difference between post administration blood uric acid and baseline

    Time frame: up to 12 weeks

  2. Duration of blood uric acid<360 μ mol/L

    Time frame: up to 12 weeks

  3. 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

07

Study locations

1 of 1 sites recruiting
  • HuaShan Hospital Fudan University project, ShangHai, China
    Shanghai, China
    Recruiting
    • hejian zhou · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06629376
Lead sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Responsible party
Sponsor
First posted
Oct 8, 2024
Start date
Nov 20, 2023
Primary completion
Dec 20, 2026 (estimated)
Completion
Aug 8, 2027 (estimated)
Last update
May 28, 2025

Study contacts

hejian zou, professor
Contact
mail@hjzou.com/zhangj_fudan@163.com
021-52889999

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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