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Hyaluronidase Assisted Subcutaneous Infusion

NCT06604546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-09-23

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

hyaluronidase

150 IU group D1:150 IU hyaluronidase+500 ml Lactated Ringer's (LR)(Subject's left or right leg)； D2:150 IU hyaluronidase+250 ml Lactated Ringe's (LR)(Subject's left or right arm)； D3:150 IU hyaluronidase+500 ml Normal Saline (NS)(subject's left or right leg)； D4:150 IU hyaluronidase+1000 ml Lactated Ringer's (LR)(Subject's back)； 385 IU group D1:385 IU hyaluronidase+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； 1500 IU group D1:1500 IU hyaluronidase+250 ml Lactated Ringer's (LR)(Subject's left or right arm).

DRUG

Placebo

150 IU group D1:Placebo+500 ml Lactated Ringer's (LR)(Subject's left or right leg)； D2:Placeboe+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； D3:Placebo+500 ml Normal Saline (NS)(Subject's left or right leg)； 385 IU group D1:Placebo+250 ml Lactated Ringer's (LR)(Subject's left or right arm)； 1500 IU group D1:Placebo+250 ml Lactated Ringe's (LR)(Subject's left or right arm).

Sponsors & Collaborators

  • Shanghai Bao Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2024-05-05
Completion
2024-08-10

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604546 on ClinicalTrials.gov