The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
HLXTE-HAase02 is a proprietary recombinant human hyaluronidase, with a molecular weight of approximately 49 kDa, is expressed in Chinese Hamster Ovary (CHO) cells and is intended for formulation development.
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety Endpoint
Time frame: From enrollment to 21 days after the second dose
Incidence of hypersensitivity reactions
Safety Endpoint
Time frame: From enrollment to 21 days after the second dose
Incidence of injection site reactions (ISRs)
Safety Endpoint
Time frame: From enrollment to 21 days after the second dose
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Pharmacokinetic (PK) parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Time frame: From enrollment to 21 days after the second dose
Area under the concentration-time curve from time zero to to the last measurable concentration (AUC0-t)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Time frame: From enrollment to 21 days after the second dose
Maximum serum concentration (Cmax)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Time frame: From enrollment to 21 days after the second dose
Time to maximum serum concentration (Tmax)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Time frame: From enrollment to 21 days after the second dose
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Terminal elimination half-life (T1/2)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Time frame: From enrollment to 21 days after the second dose
Terminal elimination rate constant (λz)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Time frame: From enrollment to 21 days after the second dose
Extrapolation percentage of AUC (%AUCex)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Time frame: From enrollment to 21 days after the second dose
Positive rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Immunogenicity
Time frame: From enrollment to 21 days after the second dose
Subcutaneous injection rate (mL/min)
Injection-related indicators
Time frame: From enrollment to 21 days after the second dose
Mean of triplicate abdominal circumference measurements
Injection-related indicators
Time frame: From enrollment to 21 days after the second dose