Gout Clinical Trial
Official title:
A Randomized, Double-blinded, Placebo-controlled, Single-dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SSS11 Administered Intravenously in Healthy Volunteers.
SSS11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kDa PEG molecules. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SSS11 administered intravenously in healthy volunteers.
Objectives:
Primary:
• To assess the safety, tolerability of single dose SSS11 in healthy subjects
Secondary:
• To assess the pharmacokinetics, pharmacodynamics and immunogenicity of SSS-11 in healthy
subjects
Enrollment and Number of Arms (planned):
40 subjects will be assigned into 5 dosing cohorts (1.5, 3, 6, 12 and 24mg) with 5-10
subjects each.
Original primary outcome Measures:
Safety: Physical exam，ECG，Clinical laboratory tests，AE，SAE Tolerance assessment：MDT，DLT
Original secondary outcome Measures:
pharmacokinetics: Cmax, Tmax, AUC, CL, Vd, t1/2 pharmacodynamics: level of serum uric acid
Immunogenicity ：anti-SSS11, anti-uricase and anti-PEG antibodies
;
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