Status:
COMPLETED
Hyaluronidase Assisted Subcutaneous Infusion
Lead Sponsor:
Shanghai Bao Pharmaceuticals Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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).
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
March 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06604546
Start Date
March 28 2024
End Date
August 10 2024
Last Update
September 23 2024
Active Locations (1)
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1
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215000