Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604546
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Hyaluronidase Assisted Subcutaneous Infusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pharmacodynamic Clinical Trail of Recombinant Human Hyaluronidase Assisted Subcutaneous Infusion in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Ringers lactated sodium into the lateral thighs bilaterally on D1 250 mL Ringers lactated sodium into the upper arms bilaterally on D2 500 mL sodium chloride injection into the lateral thighs bilaterally on D3 and 1000 mL Ringers lactated sodium into the back on D4 as scheduled
Subjects in the 385 IU group received a 250 mL subcutaneous infusion of Ringers lactated sodium into the bilateral upper arms on D1 as scheduled
Subjects in the 1500 IU group received a 250 mL subcutaneous infusion of Ringers lactated sodium into the bilateral upper arms on D1 as scheduled
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 Ringers lactated sodium into the lateral thighs bilaterally on D1 250 mL Ringers lactated sodium into the upper arms bilaterally on D2 500 mL sodium chloride injection into the lateral thighs bilaterally on D3 and 1000 mL Ringers lactated sodium into the back on D4 as scheduled
Subjects in the 385 IU group received a 250 mL subcutaneous infusion of Ringers lactated sodium into the bilateral upper arms on D1 as scheduled
Subjects in the 1500 IU group received a 250 mL subcutaneous infusion of Ringers lactated sodium into the bilateral upper arms on D1 as scheduled
Detailed Description:
Hyaluronic acid HA is an acidic mucopolysaccharide widely found in connective tissues such as the intercellular matrix of human tissues the vitreous humour of the eye and the synovial fluid of the joints and is a component of the tissue matrix that acts to restrict the diffusion of water and other extracellular substances Its gel-like nature makes it a barrier to subcutaneous fluid diffusion and is an important limitation to subcutaneous infusion It has also been reported in the literature that lymph nodes liver and skin are the major metabolic sites of HA with a metabolic half-life in the skin of approximately 15-20 h This means that the structure of HA destroyed by enzymatic cleavage can be autonomously rebuilt within 24-48 h The rapid metabolism characteristics of HA make it an ideal target for action Hyaluronidase is an endoglycosidase capable of degrading and oligomerising HA HAase hydrolyses the β-14 glycosidic linkage in the HA chain to yield small molecules of HA or oligosaccharides thereby increasing tissue permeability and improving the permeability of tissues to fluids HAase has been used in the medical field for many years as a drug diffusing agent which can promote the diffusion of locally stored drugs exudate or blood accelerate the absorption of drugs reduce local tissue tension and pain and facilitate the absorption and drainage of oedema and inflammatory exudate Clinically HAase is used clinically as an adjunct to subcutaneous infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None