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The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLXTE-HAase02, in healthy Chinese adult male subjects | Experimental | The study consists of three sequential dose-escalation cohorts, with a planned total of approximately 24 subjects (8 subjects per cohort). HLXTE-HAase02 will be administered via subcutaneous (SC) injection at a diluted concentration of 2000 U/mL. The three dose levels are 5 mL, 15 mL, and 25 mL. Each subject will receive the administration on D1 and D8. No intra-patient dose escalation is allowed. The safety of injection site reactions (ISRs) will be evaluated by the Safety Review Committee (SRC) based on their severity, incidence, and other factors to discuss the safety and determine the eligibility for escalation to the next dose level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human hyaluronidase | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety Endpoint | From enrollment to 21 days after the second dose |
| Incidence of hypersensitivity reactions | Safety Endpoint | From enrollment to 21 days after the second dose |
| Incidence of injection site reactions (ISRs) | Safety Endpoint | From enrollment to 21 days after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Jin | Contact | +86 15955160489 | qi_jin@henlius.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Hu | The Second Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
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PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher). |
| 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). | 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). | From enrollment to 21 days after the second dose |
| Terminal elimination half-life (T1/2) | PK parameter calculated using non-compartmental analysis (NCA) with WinNonlin version 8.2 (or higher). | 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). | 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). | From enrollment to 21 days after the second dose |
| Positive rates of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) | Immunogenicity | From enrollment to 21 days after the second dose |
| Subcutaneous injection rate (mL/min) | Injection-related indicators | From enrollment to 21 days after the second dose |
| Mean of triplicate abdominal circumference measurements | Injection-related indicators | From enrollment to 21 days after the second dose |