Promote the diffusion of subcutaneous infusion to replace intravenous infusion
Conditions
Interventions
control group:Single subcutaneous administration of placebo
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the trial and sign an informed consent; 2. Male and female subjects aged 18 to 60 years (including 18 and 60 years); 3. The weight of male subjects should not be less than 50 kg, and the weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/ height2(m2), and the body mass index should be in the range of 19~26kg/m2 (including the critical value); 4. From the date of signing the informed consent, female or male subjects with reproductive capacity and their partners should use appropriate and effective contraceptive methods, such as abstinence, intrauterine devices, or double barrier methods (e.g., condoms plus diaphragm), and have no plans for sperm donation or egg donation, ensuring that they do not plan to have children from the start of the study until 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. The investigator assessed the current or previous history of clinically significant diseases such as heart, liver, kidney, digestive tract, nervous system, respiratory system, mental and metabolic abnormalities; the vital signs, physical examination, 12-lead electrocardiogram or laboratory test results were abnormal with clinical significance; 2. Abnormal antibodies to human immunodeficiency virus (HIV), hepatitis C virus (HCV), syphilis specific antibodies or hepatitis B virus (HBV) surface antigen; 3. Those who are allergic to recombinant human hyaluronidase or its preparation ingredients, or have a history of allergic diseases, allergic constitution, or allergic to any kind of drugs, or allergic to two or more foods; 4. Those who have special requirements for diet and cannot comply with the unified diet; 5. Those who have used any prescription drugs, over-the-counter drugs or Chinese herbal medicines within 4 weeks prior to screening (especially salicylates, cortisone, ACTH, estrogen or antihistamines, except for routine vitamin supplements), or are still within 5 half-lives of the drugs (whichever is longer); 6. Those who donated blood or lost blood volume of more than 400 mL within 3 months before screening; 7. Those with drug dependence, abuse and drug use history; 8. Urine drug abuse screening (including morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine) positive individuals; 9. Female subjects are pregnant or lactating, or the quantitative result of serum ß-human chorionic gonadotropin exceeds the upper limit of normal range; 10. Participants who had participated in other clinical trials within 3 months prior to screening; 11. The observation and evaluation of the subject's upper arm or abdomen on either side is affected by skin lesions, inflammation, tattoos, etc.; 12. Those who have had surgery within 4 weeks before screening or are scheduled to have surgery during the trial; 13. Those who are dizzy, have difficulty in blood collection, or cannot tolerate venipuncture or blood collection; 14. Those who have a positive result in the tobacco inspection or cannot stop using any tobacco products during hospitalization; 15. Those who have a positive alcohol breath test or cannot stop drinking during hospitalization; 16. Consumed starfruit, papaya, dragon fruit, grapefruit or its products within 48 hours before the first administration of the test drug, or could not be interrupted during hospitalization; 17. Drink excessive caffeinated beverages (more than 8 cups a day, 1 cup =250 mL) every day for 3 months before screening, or consume any caffeinated food or beverage (such as coffee, tea, cola, soda and chocolate) within 48 h before the first dose of the trial, or cannot be interrupted during hospitalization; 18. Significant changes in diet or exercise habits (such as dieting, binge eating, etc.) within 3 months before screening or strenuous exercise within 48 h before administration; 19. The investigator considers that the subject is not suitable for participation in the trial, or the subject cannot participate in the trial for his own reasons. * For subcutaneous injection in the upper arm, abdominal injection is not required; for subcutaneous injection in the abdomen, upper arm injection is not required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event; Pharmacokinetics;positive rate of anti-drug antibodies; | — |
Countries
China
Contacts
Public ContactMinggang Wang; Shumin Wang
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed