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Published on: February 7, 2021
Recombinant human hyaluronidase PH20 facilitates rapid subcutaneous infusion: two randomized, double-blind,
Haiping Ma1, Xiaoyu Lu2, Jianping Xiu1
1Clinical Research Unit, The First Affiliated Hospital of Naval Medical University, Shanghai, China.
Background:
Hyaluronidases (HAase) increase tissue permeability by depolymerizing hyaluronan in the extracellular matrix. Consequently, the subcutaneous (SC) delivery of substantial volumes of fluids or biotherapeutics is facilitated. Recombinant human hyaluronidase PH20 (rHuPH20) has been developed to overcome the allergic and immunologic risks associated with animal-derived HAase. However, standalone rHuPH20 products remain unavailable in China despite increasing clinical demand.
Methods:
Two randomized, double-blind, self-controlled phase III clinical trials (phase IIIa and IIIb) were conducted to evaluate the SC infusion rate, tolerability and safety of KJ017, a rHuPH20, in healthy participants receiving gravity-driven SC infusion. The primary outcome was SC infusion rate. The secondary outcomes included arm circumference, time to recover baseline arm circumference, and safety evaluations, such as adverse events (AEs).
Results:
Across both trials, SC infusion rates in all KJ017 groups (128/150 IU, 385 IU, and 1540/1500 IU) were significantly higher than those in the placebo groups (all P < 0.001). KJ017 administration was associated with minimal increases in limb circumference at the infusion site, suggesting reduced local fluid accumulation and more efficient tissue dispersion of the infused solution. SC administration of KJ017 across a dose range of 128 IU to 1540 IU was well tolerated and safe, and no allergic reactions were documented.
Conclusions:
These phase III trials demonstrate that KJ017 effectively enhances gravity-driven SC infusion performance while maintaining favorable safety and tolerability. By increasing SC tissue permeability, KJ017 enables the delivery of clinically relevant fluid volumes through the SC route across multiple anatomical sites. These findings support the further development of KJ017 as an enabling agent for large-volume SC administration and for potential co-administration with therapeutic agents requiring rapid or high-volume SC delivery. Trial registrationChictr.org.cn, ChiCTR2100049727 and ClinicalTrials.gov, NCT06604546.
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