Halozyme’s Enhanze Technology is based on recombinant human PH20 hyaluronidase (rHuPH20). This current clinical trial is designed to compare the pharmacokinetics, safety and tolerability of a large molecule protein therapeutic agent subcutaneously injected both with and without rHuPH20.
The study will use escalating doses of rHuPH20 and substitute a standard subcutaneous (SC) injection of the therapeutic agent with a SC injection of the protein therapeutic agent combined with rHuPH20. The study will compare the bioavailability and other pharmacokinetic parameters, along with safety and tolerability, of the two SC injections, one with and one without rHuPH20.
“The initiation of this clinical trial takes us another step closer to further developing the full potential of the human recombinant form of hyaluronidase,” said Dr Richard Yocum, vice president of clinical development and medical affairs at Halozyme.
“If rHuPH20 can be shown to enhance the absorption of large molecule therapeutics and confer benefit either by improved bioavailability, time to absorption, and/or reduced side effects, this method of drug administration may open up new strategies to treating patients with regard to doses administered, dosing intervals, patient tolerability, patient convenience, and health economics.”