Monoclonal Antibody Drugs for Type I Interferon Receptor 1
Conditions
Interventions
experimental group:Randomly assigned to receive GR1603 injection (0.1mg/kg, 0.3mg/kg, 1mg/kg, 3mg/kg) or placebo
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. 18-50 years old (including 18 and 50 years old), no gender limits; 2. BMI (body mass index): 18.0-28.0 kg/m^2 (including 18.0 and 28.0kg/m^2); male subjects weigh >=50.0kg, female subjects weigh >= 45.0kg; 3. Able to understand and abide by the requirements of the clinical program, voluntarily participate in the clinical trial, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. There is active infection, or medical history: (1) Systemic anti-infection treatment has been performed within 4 weeks before screening; (2) There are recurrent, chronic or other active infections at the time of screening, which may increase the risk of subjects after the researcher's assessment and judgment; 2. Have a history of active tuberculosis, or have active tuberculosis infection at the time of screening, or TB-spot (or similar tuberculosis infection test test, such as PPD test) is positive at the time of screening; 3. Subjects who have a clear history of the central nervous system, cardiovascular system, kidneys, liver, digestive system, respiratory system, metabolic system or other significant diseases that the investigator considers to be clinically significant; 4. Have a history of lymphoproliferative diseases; or currently have malignant tumors or have a history of malignant tumors (squamous cell carcinoma in situ, basal cell carcinoma and cervix in situ of the skin more than 5 years after complete remission after radical treatment without any signs of recurrence Except for cancer); 5. Subjects with a history of mental illness; 6. Have a history of serious herpes virus infection, such as: herpes encephalitis, ocular herpes, disseminated herpes, etc.; 7. Upon questioning, subjects who have participated in clinical trials of other drugs within 3 months before screening; or have used drugs that are known to cause damage to major organs within 3 months before screening; 8. Subjects who have donated blood >= 400 mL within 4 weeks before screening, or have severe blood loss within 4 weeks before screening and the blood loss is at least equivalent to 400 mL, or have received blood transfusion within 8 weeks, or plan to donate blood during the study period; 9. Subjects who have received live/attenuated vaccination within 4 weeks before screening or plan to receive live/attenuated vaccination during the trial period; 10. Subjects who have undergone surgery within 4 weeks before screening, or plan to undergo surgery during the study period; 11. Subjects who have taken any medicine or health care products (including Chinese herbal medicine) within 14 days before screening; 12. Any drug that inhibits or induces liver metabolism of drugs has been used within 30 days before screening (Such as inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitro Imidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 13. Upon questioning, subjects who are known to be allergic to test drugs (including excipients, similar drugs), or suffer from severe allergic diseases or have allergies (such as allergies to two or more drugs, food or pollen), according to the judgment of the investigator, the safety of the subject may be compromised; 14. Upon questioning, subjects who have a history of drug abuse or drug abuse, or subjects who are positive on the baseline drug abuse screening; 15. Upon questioning, smoking more than 5 cigarettes or equivalent amount of tobacco a day within 3 months; 16. Alcoholics or frequent drinkers in the 6 months before screening, that is, drinking more than 14 units of alcohol per week (1 unit = 360ml beer or 45ml 40% alcoholic spirits or 150ml wine), or alcohol exhalation during the baseline period Subjects who test positive; 17. Abnormal vital signs (systolic blood pressure 140 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity;Type I IFN gene transcription level; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed