Systemic lupus erythematosus
Conditions
Interventions
Test group:Single intravenous infusion of QX006N
Control group:Conventional treatment
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 18 to 50 (including both ends) when signing the informed consent; 2. Male subjects weigh >= 50 kg, female subjects weigh >= 45 kg, and both are <= 100 kg; body mass index (BMI=weight/height squared (kg/m2)) is 18~28 kg/m^2 range (including both ends); 3. After a comprehensive examination, including vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, abdominal color Doppler ultrasound and frontal chest radiograph, the examinations are normal or abnormal but have no clinical significance; 4. Agree to have no reproductive plan and voluntarily take effective contraceptive measures during the trial and within 6 months after the trial; 5. The subjects fully understand the purpose, nature, methods and possible adverse reactions of the test, volunteer as subjects, and sign the informed consent; those who can complete the test according to the requirements of the program.
Exclusion criteria
Exclusion criteria: 1. Those who have previously received drugs with the same target (IFNAR1); 2. Those who have a history of drug or other allergies and the investigator believes that the risk of participating in this study is higher, or who may be allergic to the study drug or any component of the study drug according to the investigator's judgment; 3. Those who have a history of drug abuse within five years before screening or who have used drugs within 3 months before the test; or those who have positive urine drug abuse screening; 4. HBsAg positive in two pairs and half of hepatitis B (if HBsAg is negative, HBcAb is positive, HBV DNA quantitative test needs to be added [if positive is excluded]), hepatitis C antibody, Treponema pallidum antibody, HIV antigen/antibody positive test; 5. Those with infection (including chronic or local infection) within 7 days before screening, those with a history of repeated infection and underlying diseases that are prone to infection, disseminated herpes simplex infection or recurrent (>1 time) or disseminated zone History of herpes zoster, history of opportunistic infection; 6. Those with a history of active tuberculosis, or those with active or latent tuberculosis infection during screening; 7. The following diseases with abnormal laboratory test results or clinical significance within 6 months before screening, including but not limited to gastrointestinal tract, kidney, liver, lung, nerve, blood, endocrine, tumor, immunity, metabolism, Mental or cardiovascular and cerebrovascular diseases, etc.; 8. Donated blood >=400mL within 4 weeks before screening, or blood loss >=400mL, or received blood transfusion within 8 weeks before screening; 9. Those who plan to be vaccinated with live (attenuated) vaccine within 4 weeks before screening or during the trial; 10. Have used any prescription drugs, Chinese herbal medicines, or used over-the-counter or dietary supplements (including vitamins, calcium supplements, etc.) within 2 weeks before screening; 11. Smoking more than 5 cigarettes per day or habitually using nicotine-containing products within 3 months before screening; 12. Drink more than 14 units of alcohol per week within 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine) or have taken alcoholic products 2 days before administration By; 13. Those who have participated in clinical trials of any drug or medical device within 3 months or 5 half-lives (whichever is longer) before screening; 14. Female subjects with positive pregnancy test or breastfeeding; the investigator believes that any other situation that may affect the subject's provision of informed consent or follow the trial protocol, or the subject's participation in the trial may affect the trial results or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed