Hyaluronidase Assisted Subcutaneous Infusion

NCT06604546 | Completed Phase 3

• 1 other identifier: SHBJ-KJ017-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Subcutaneous infusion rate.

  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).

  Within 4 hours after starting subcutaneous infusion.

Secondary Outcomes (3)

• Immunogenicity

  day 21

• Measurement value of limb circumference

  day 4

• Adverse events

  day 7

Study Arms (2)

hyaluronidase group

EXPERIMENTAL

Drug: hyaluronidase

Placebo self control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

hyaluronidase DRUG

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).

Also known as: Lactated Ringer's (LR), Normal Saline (NS)

hyaluronidase group

Placebo DRUG

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).

Also known as: Lactated Ringer's, Normal Saline

Placebo self control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must be willing to participate in this study and sign a written informed consent form.
• Male or female, 18 to 60 years of age.
• Male subjects weighing at least 50 kg, female subjects weighing at least 45 kg. Body mass index in the range of 18-28 kg/m2 (including threshold values).

You may not qualify if:

• Positive for HBsAg, HCV antibody, HIV antibody and syphilis antibody at screening.
• Definite hypersensitivity to recombinant human hyaluronidase for injection or any of the components of its preparation. Severe allergic reaction (e.g. angioedema) to any medication. Special dietary requirements or inability to follow the standard diet required by the clinical trial site.
• Prescription medicines taken within 14 days or 5 half-lives prior to dosing, or over-the-counter medicines (including proprietary Chinese medicines and herbal remedies) taken within 7 days or 5 half-lives prior to dosing. Regular vitamin supplementation was excluded, but special cases of medication that, in the opinion of the investigator, did not interfere with the evaluation of the study could be included.
• Blood donation or blood loss of 400 mL or more in the 3 months prior to screening.
• Heavy smoking (25 or more cigarettes per day).
• Alcohol abuse or a positive breath test result for alcohol.
• Positive urine drug screen (including morphine, methamphetamine, ketamine).
• Received another investigational drug (or investigational device) within 28 days or at least 5 half-lives prior to screening, whichever is longer.
• The subject or partner is planning to have a child or is unwilling to use effective contraception during the trial or for 6 months after the end of the trial.
• Nursing or pregnant women.
• Inflammation, tattoos, skin lesions, and scarring on both limbs may interfere with observation and assessment.
• Extremities oedema and limb pathology that may affect test results (e.g. cellulitis, lymphatic disorders or history of surgery, history of mastectomy, history of pre-existing pain syndrome or axillary lymph node dissection).
• Sensorimotor and voluntary movement disorders.
• Circumstances such as the investigator's opinion that participation in the trial is inappropriate or that the subject is unable to participate in the trial.

Sponsors & Collaborators

• Shanghai Bao Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Interventions

Hyaluronoglucosaminidase; Ringer's Lactate; Saline Solution

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: March 28, 2024
• Primary Completion: May 5, 2024
• Study Completion: August 10, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CN (1)