Hyaluronidase Assisted Subcutaneous Infusion

Summary

A randomised, double-blind, self controlled study to evaluate the pharmacodynamics and safety of recombinant human hyaluronidase assisted subcutaneous infusion in healthy subjects. Recombinant human hyaluronidase or placebo was injected subcutaneously at the prescribed site on the day of administration. The prescribed fluid was then infused subcutaneously. Subjects in the 150 IU group received a subcutaneous infusion of 500 mL Ringer's lactated sodium into the lateral thighs bilaterally on D1, 250 mL Ringer's lactated sodium into the upper arms bilaterally on D2, 500 mL sodium chloride injection into the lateral thighs bilaterally on D3, and 1,000 mL Ringer's lactated sodium into the back on D4, as scheduled. Subjects in the 385 IU group received a 250 mL subcutaneous infusion of Ringer's lactated sodium into the bilateral upper arms on D1 as scheduled. Subjects in the 1500 IU group received a 250 mL subcutaneous infusion of Ringer's lactated sodium into the bilateral upper arms on D1 as scheduled.

Timeline

Start

2024-03-28

Primary completion

2024-05-05

Completion

2024-08-10

Outcome

Met primary endpoint

paper were significantly higher than those in the placebo groups (all P < 0.001). PMID 41935547 ↗

Publications

• Ma H, Lu X, Xiu J, Cao M, Li J, Qiao Y, Liu Y, Wang Z, Zhang L, Qian X, Zhang H, Tang H, Zhao N, Yu Y, Zhang L. Recombinant human hyaluronidase PH20 facilitates rapid subcutaneous infusion: two randomized, double-blind, self-controlled phase III clinical trials. Eur J Pharm Biopharm. 2026 Jun;223:115070. doi: 10.1016/j.ejpb.2026.115070. Epub 2026 Apr 2.

Drugs

Indications

No indication recorded.