Facilitating subcutaneous fluid administration
Conditions
Interventions
Experimental group 1:????500?????????
Experimental group 2:1500 units of recombinant human hyaluronidase subcutaneously
Experimental group 3:6000 units of recombinant human hyaluronidase subcutaneously
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in the study and sign the informed consent form; 2.Male and female subjects aged 18 ~ 60 years (including 18 and 60 years); 3.The weight of male subjects shall not be less than 50 kg and that of female subjects shall not be less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), and the body mass index is in the range of 18-28 kg / m2 (including the critical value); 4.There was no past or current history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic abnormalities that were considered by the researchers to be uncontrolled within 1 year before enrollment; The results of vital signs, physical examination and ECG were normal or abnormal, and had no clinical significance
Exclusion criteria
Exclusion criteria: 1.HBsAg, HCV antibody, HIV antibody, syphilis antibody screening positive; 2.Clearly allergic to recombinant human hyaluronidase for injection or its preparations; Have a history of allergy to drugs (including salicylic acid), allergic disease or allergic constitution; Those who have special dietary requirements or cannot follow a uniform diet within 12 hours before starting infusion; 3.Those who have used any prescription drugs, over-the-counter drugs or Chinese herbal medicines (especially salicylic acid, cortisone, corticotropic hormone, estrogen or antihistamine, except for routine vitamin supplements) within 2 weeks prior to screening; 4.Blood donation or blood loss >=400 mL within 3 months before screening; 5.Heavy smoker (25 or more cigarettes a day); 6.Alcoholics (14 units of alcohol per week :1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine) or those who have a positive breath test for alcohol; 7.Those with a history of drug dependence, abuse or drug use in the previous five years; 8.Urine screening positive for drug abuse (including morphine, methamphetamine, ketamine); 9.Those who participated in other clinical trials and used the investigational drug within 3 months prior to screening; 10.The subject or his/her partner has a family plan or is unwilling to take effective contraceptive measures during the study period or within 6 months after the end of the study; 11.Inflammation, tattoos, skin lesions and scars on both upper arms of the subject affect observation and evaluation; 12.Edema of the limbs and upper limb lesions that may affect the results of the study (e.g., cellulitis, lymphatic disorders or a history of surgery, mastectomy, a history of pre-existing pain syndrome, or axillary lymph node dissection, etc.); 13.Subjects' sensorimotor disorders and autonomic motor disorders; 14.The researcher considers that it is not suitable to participate in the study, or the subjects cannot participate in the study due to their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of subcutaneous infusion;arm circumference;adverse event;immunogenicity; | — |
Countries
China
Contacts
Public ContactZhu Zhen
Shanghai Bao Pharmaceuticals Co., Ltd.
Outcome results
None listed