To evaluate the safety, tolerability, PK and preliminary PD of SSS11 for injection in chinese healthy adult volunteers.
This is a phase I, open label, single-dose, dose-increasing study to assess the safety, tolerability and PK characteristics of healthy humans after injection of SSS11, provide a reference for subsequent clinical studies and give preliminary assessment of the immunogenicity and PD of SSS11.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
PEGylated recombinant candida urate oxidase is a combination of 20kDa linear polyethylene glycol (PEG) linked to Candida utilis recombinant uricase by succinimide succinate
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGAdverse events (AEs)
Number of subjects with Adverse events (AEs)
Time frame: From the day signing in informed consent form to the day 56 post-dose
DLT
Dose-LimitingToxicity of SSS11
Time frame: From day 1 to day 56
Cmax
Maximum plasma concentration (Cmax) of single dose SSS11
Time frame: From beginning of drug administration to day 56
Tmax
Peak plasma time \[tmax\] of single dose SSS11
Time frame: From beginning of drug administration to day 56
AUC
Area under the plasma concentration versus time curve (AUC) of single dose SSS11
Time frame: From beginning of drug administration to day 56
Anti-urate oxidase antibody
The immunogenicity of SSS11 was assessed in subjects by detecting the anti-urate oxidase antibody.
Time frame: From pre-dose on week 2 up to week 1, 2, 4 and 7 post-dose.
Uric acid levels in blood
This parameter was used to evaluate the PD of SSS11 in healthy humans.
Time frame: From beginning of drug administration to day 56
Uric acid levels in urine
This parameter was used to evaluate the PD of SSS11 in healthy humans.
Time frame: From beginning of drug administration to day 6
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