Healthy Adult Male
Conditions
Brief summary
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
Interventions
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.
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Physical examination, vital signs, electrocardiogram (ECG), chest X-ray, and clinical laboratory tests are normal or abnormal without clinical significance (NCS). * Subjects must agree to use highly effective contraception with their spouse or partner from the time of signing the Informed Consent Form (ICF) until 3 months after the last dose, or the subject is not capable of reproduction. Subjects must also refrain from sperm donation during the study and for 3 months following the last dose of the investigational product. * Voluntarily signed the Informed Consent Form (ICF) prior to any study procedures, with a full understanding of the study content, procedures, and potential adverse events (AEs); and the ability to comply with the protocol requirements to complete the study.
Exclusion criteria
* 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. * Known allergy to recombinant human hyaluronidase for injection or its formulation components; history of severe allergic reactions to any medication (e.g., angioedema); special dietary requirements or inability to comply with the standardized diet provided by the clinical site. * Use of any prescription drugs, over-the-counter (OTC) medications, or herbal medicines within 4 weeks prior to screening (especially salicylates, cortisone, adrenocorticotropic hormone, estrogens, or antihistamines, except for routine vitamin supplements), or within 5 half-lives of the medication (whichever is longer). * Vaccination within 1 month prior to administration. * History of blood donation or blood loss ≥ 400 mL within 3 months prior to the use of the investigational product. * Participation in any other clinical study and use of investigational/control products within 3 months prior to the investigational product administration. * Positive for HBsAg, anti-HCV, anti-HIV, or the syphilis spirochete test. * Sensory-motor disorders or autonomic movement disorders. * Any condition which, in the investigator's judgment, would make the subject unable to comply with the protocol requirements, instructions, or study restrictions, such as an uncooperative attitude, inability to return for follow-up visits, or inability to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From enrollment to 21 days after the second dose | Safety Endpoint |
| Incidence of hypersensitivity reactions | From enrollment to 21 days after the second dose | Safety Endpoint |
| Incidence of injection site reactions (ISRs) | From enrollment to 21 days after the second dose | Safety Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-inf) | From enrollment to 21 days after the second dose | 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) | From enrollment to 21 days after the second dose | PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher). |
| Maximum serum concentration (Cmax) | From enrollment to 21 days after the second dose | PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher). |
| Time to maximum serum concentration (Tmax) | From enrollment to 21 days after the second dose | PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher). |
| Terminal elimination half-life (T1/2) | From enrollment to 21 days after the second dose | PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher). |
| Terminal elimination rate constant (λz) | From enrollment to 21 days after the second dose | PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher). |
| Extrapolation percentage of AUC (%AUCex) | From enrollment to 21 days after the second dose | PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher). |
| Positive rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) | From enrollment to 21 days after the second dose | Immunogenicity |
| Subcutaneous injection rate (mL/min) | From enrollment to 21 days after the second dose | Injection-related indicators |
| Mean of triplicate abdominal circumference measurements | From enrollment to 21 days after the second dose | Injection-related indicators |
Countries
China
Contacts
CONTACTQi Jin
PRINCIPAL_INVESTIGATORWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed