The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
Healthy male subjects, aged ≥ 18 and ≤ 45 years.
Body Mass Index (BMI) ≥ 18.0 and ≤ 28.0 kg/m².
Intact skin at the injection site, with no damage, tattoos, or other markings.
No significant medical history, or a history of abnormalities that, in the investigator's judgment, will not impact the study.
History of drug abuse or or substance use, or a positive drug screen; history of long-term heavy alcohol consumption (defined as consuming more than 14 units of alcohol per week within 3 months prior to screening [1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine]) or a positive blood alcohol test; history of long-term heavy alcohol use or positive blood alcohol test; history of long-term heavy smoking (defined as an average of more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from smoking during the ).
Cardiac disorders, including but not limited to clinically significant ECG abnormalities during the screening period, QTcF > 450ms, or a history of clinically significant ECG abnormalities.
History of any clinically severe hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or oncological diseases, or allergic diseases.
History of upper respiratory tract infection or other acute infections within 7 days prior to the first dose, or systemic use of antibiotics within 7 days.
Single group
recombinant human hyaluronidase
DrugHLXTE-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.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety Endpoint
Incidence of hypersensitivity reactions
Safety Endpoint
Incidence of injection site reactions (ISRs)
Safety Endpoint
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).
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).
Maximum serum concentration (Cmax)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
Time to maximum serum concentration (Tmax)
PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher).
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