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

Recruiting Phase 1 Interventional Study
Gout Hyperuricemia
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
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About This Trial
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 experi…
Trial Locations
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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}。 * Screen…
Contacts

hejian zou, professor

021-52889999

mail@hjzou.com/zhangj_fudan@163.com

CONTACT