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
Overview
- Phase
- Phase 1
- Intervention
- Pegylated Recombinant Candida Utilis Uricase for Injection
- Conditions
- Gout
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The primary outcome was safety.
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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。
Investigators
Eligibility Criteria
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)。
Arms & Interventions
Experimental： group3
injection；strength；12mg
Intervention: Pegylated Recombinant Candida Utilis Uricase for Injection
Experimental： group4
injection；strength；16mg
Intervention: Pegylated Recombinant Candida Utilis Uricase for Injection
Experimental： group2
injection；strength；8mg
Intervention: Pegylated Recombinant Candida Utilis Uricase for Injection
Experimental： group1
injection；strength；4mg
Intervention: Pegylated Recombinant Candida Utilis Uricase for Injection
Experimental： group5
injection；strength；20mg
Intervention: Pegylated Recombinant Candida Utilis Uricase for Injection
Placebo control group
The same volume of placebo as SSS11
Intervention: Pegylated Recombinant Candida Utilis Uricase for Injection
Outcomes
Primary Outcomes
The primary outcome was safety.
Time Frame: up to 12 weeks
Assessment AEs by frequency and severity
Secondary Outcomes
- 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)