Hyaluronidase Assisted Subcutaneous Infusion
- Registration Number
- NCT06604546
- Lead Sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
- Brief Summary
A randomized, 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 injection into the lateral thighs bilaterally on D1, 250 mL Ringer's lactated sodium injection 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 injection 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 sodium lactate Ringer's solution 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 (EC 3.2.1.35), or hyaluronidase, is an endoglycosidase capable of degrading and oligomerising HA. HAase hydrolyses the β-1,4 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description hyaluronidase group hyaluronidase - Placebo self control group Placebo -
- Primary Outcome Measures
Name Time Method Subcutaneous infusion rate. Within 4 hours after starting subcutaneous infusion. Subcutaneous infusion Rate: defined as Infusion Rate = (Base Infusion Bag Weighing Weight - Final Infusion Bag Weighing Weight) x (1 mL/g)/(Infusion Completion Time - Infusion Start Time).
- Secondary Outcome Measures
Name Time Method Immunogenicity day 21 antidrug antibodies (ADA) level
Measurement value of limb circumference day 4 Limb circumference measurements: Limb circumference measurements were used to assess the pharmacodynamic and safety profile of subcutaneous infusions in healthy volunteers. Limb circumference was measured at the time of each subcutaneous infusion in the upper arm or thigh and at the end of the infusion until the limb circumference returned to baseline (±2 cm).
Adverse events day 7 The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities \[MedDRA\]). Adverse events assessed by CTCAE v5.0.
Trial Locations
- Locations (1)
Suzhou Municipal Hospital
🇨🇳Su Zhou, Jiangsu, China