GoutPhase 1NCT06629376
Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
A Phase 1 study testing Pegylated Recombinant Candida Utilis Uricase for Injection in people with Gout and Hyperuricemia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- Pegylated Recombinant Candida Utilis Uricase for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 8 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)。
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
HuaShan Hospital Fudan University project, ShangHai, China
Shanghai
hejian zhou
About this study
Official title: 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。
- Conditions
- Gout, Hyperuricemia
- Being tested
- Pegylated Recombinant Candida Utilis Uricase for Injection
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Recombinant Candida Utilis Uricase for InjectionDrug
Also called SSS11
According to the dosage requirements of each experimental group, intravenous infusion should be administered for at least 2 hours each time
| Study group | Role | What they receive |
|---|---|---|
| Experimental： group1 | Experimental | injection；strength；4mg Receives: Drug: Pegylated Recombinant Candida Utilis Uricase for Injection |
| Experimental： group2 | Experimental | injection；strength；8mg Receives: Drug: Pegylated Recombinant Candida Utilis Uricase for Injection |
| Experimental： group3 | Experimental | injection；strength；12mg Receives: Drug: Pegylated Recombinant Candida Utilis Uricase for Injection |
| Experimental： group4 | Experimental | injection；strength；16mg Receives: Drug: Pegylated Recombinant Candida Utilis Uricase for Injection |
| Experimental： group5 | Experimental | injection；strength；20mg Receives: Drug: Pegylated Recombinant Candida Utilis Uricase for Injection |
| Placebo control group | Placebo comparator | The same volume of placebo as SSS11 Receives: Drug: Pegylated Recombinant Candida Utilis Uricase for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was safety.
Assessment AEs by frequency and severity
Measured: up to 12 weeks
Secondary outcomes (3)
Difference between post administration blood uric acid and baseline
Measured: up to 12 weeks
Duration of blood uric acid<360 μ mol/L
Measured: up to 12 weeks
Proportion of subjects with blood uric acid levels below 360 μ mol/L at each sample collection time point
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Nov 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion8 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629376
- Sponsor's protocol ID
- SYSS-SSS11-UND-I-03
- Status last verified
- Oct 2024
- First submitted
- 6 Sep 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06629376
- Acronym / sponsor ID
- SYSS-SSS11-UND-I-03
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 8 Aug 2027 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental： group1 | Experimental | Drug: Pegylated Recombinant Candida Utilis Uricase for Injectioninjection；strength；4mg |
| Experimental： group2 | Experimental | Drug: Pegylated Recombinant Candida Utilis Uricase for Injectioninjection；strength；8mg |
| Experimental： group3 | Experimental | Drug: Pegylated Recombinant Candida Utilis Uricase for Injectioninjection；strength；12mg |
| Experimental： group4 | Experimental | Drug: Pegylated Recombinant Candida Utilis Uricase for Injectioninjection；strength；16mg |
| Experimental： group5 | Experimental | Drug: Pegylated Recombinant Candida Utilis Uricase for Injectioninjection；strength；20mg |
| Placebo control group | Placebo comparator | Drug: Pegylated Recombinant Candida Utilis Uricase for InjectionThe same volume of placebo as SSS11 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)。
Key exclusion criteria (6 listed)
- 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。
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated Recombinant Candida Utilis Uricase for InjectionAlso: SSS11According to the dosage requirements of each experimental group, intravenous infusion should be administered for at least 2 hours each time | Drug | Experimental： group1, Experimental： group2, Experimental： group3, Experimental： group4, Experimental： group5, Placebo control group |
Primary outcome
The primary outcome was safety.
Time frame: up to 12 weeks
Assessment AEs by frequency and severity
3 secondary outcomes
Difference between post administration blood uric acid and baseline
Time frame: up to 12 weeks
Duration of blood uric acid<360 μ mol/L
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pegylated Recombinant Candida Utilis Uricase for Injection in people with Gout and Hyperuricemia, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hejian zou, professor (021-52889999, mail@hjzou.com/zhangj_fudan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was safety. (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.