Huonslab has concluded enrolment of subjects in the Phase I clinical trial, a significant step in the development of the recombinant human natural hyaluronidase PH20 (rHuPH20), Hydizyme (HLB3-002).
Hydizyme is tailored to improve the dispersion and absorption of other jointly administered fluids and drugs.
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The two-part, double-blind, randomised, placebo-controlled trial aims to assess the allergenicity and safety of HLB3-002 in 243 healthy volunteers.
The first part concentrates on allergenicity assessment of the therapy following a single intradermal administration while the second focuses on the safety after a single subcutaneous administration.
The study is being carried out across four South Korean medical institutions, including Asan Medical Center, Konkuk University Medical Center, and Seoul National University Hospital.
These sites will aid in conducting the trial consistently and in subject recruitment.
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By GlobalDataBy the latter half of this year, the company anticipates submission of a biologics license application (BLA) to the Ministry of Food and Drug Safety of the Republic of Korea for marketing approval, contingent on trial results.
A Huonslab official said: “This milestone represents an important step in advancing the HLB3-002 development programme. The results of this Phase I will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying a solid foundation for future clinical trials and regulatory submission.”
A subsidiary of Huons Global, Huonslab focuses on innovating hyaluronidase-based biologics for subcutaneous delivery.
Its HyDIFFUZE platform, which utilises a patented process and recombinant Chinese hamster ovary cell line, is designed to offer a patient-friendly alternative to traditional intravenous delivery methods.
