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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2027-08-08

Brief Summary

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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。

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Detailed Description

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Conditions

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Gout Hyperuricemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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SSS11

Eligibility Criteria

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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)。

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No