KJ-017

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.

主要目的：以皮下输液的速率为指标，评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的药效学特征； 次要目的：以受试者臂围的测量值为指标，评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的药效学特征； 评价注射用重组人透明质酸酶在健康受试者中自身对照单次给药辅助皮下输液的安全性和免疫原性。