Systemic lupus erythematosus
Conditions
Interventions
0.1 mg/kg dose group:0.1mg/kg GR1603 injection
0.3 mg/kg dose group:0.3 mg/kg GR1603 injection
1mg/kg dose group:1mg/kg GR1603 injection
3mg/kg dose group:3mg/kg GR1603 injection
0.3mg/kg placebo group:0.3mg/kg placebo
1mg/kg placebo group:1mg/kg placebo
3mg/kg placebo group:3mg/kg placebo group
Sponsors
Clinical Trial Reseach Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-50 years (including 18 and 50 full years of life); Both males and females; 2. Body mass index (BMI) between 18.0 kg/m2 and 28.0 kg/m2 (including 18.0 and 28.0 kg/m2); Weight >= 50.0 kg for male and weight >= 45 kg for female; 3. Be able to understand and obey the requirements of the protocal, voluntary to participate in clinical trial and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of active infection or disease; 2. Having a history of active tuberculosis or active tuberculosis infection during the screening period or TB-spot test (or similar test for tuberculosis infection, such as PPD test) is positive during screening period; 3. Those who have a definite medical history of the central nervous system, cardiovascular system, kidney system, liver system, digestive system, respiratory system, metabolic system or other significant diseases which has clinical significance judged by the investigator; 4. Having a history of lymphoproliferative disease or malignant tumor; or being suffering from malignant tumor at present; 5. Have a history of mental illness; 6. Have a history of severe herpes virus infection; 7. After asking, those who have participated in clinical trial of other drugs within 3 months before sceening; or having used drugs known to cause damage to major organs within 3 months before screening; 8. Those who lost or donated more than 400ml of blood within 4 weeks before screening, or who have received blood transfusion within 8 weeks before screening, or plan to donate blood during the trial period; 9. Having received live or attenuated vaccine within 4 weeks before screening or plan to receive live or attenuated vaccine during the trial period; 10. Having received surgery within 4 weeks before screening, or plan to receive surgery during the trail period; 11. Those who have taken any medicine or health care products (including chinese herbal medicine) within 14 days before screening; 12. Those who have taken any drug that inhibits or induces liver metabolism within 30 days before screening; 13. Those who are known to be allergic to investigational drugs (including excipients, similar drugs), or suffer from severe allergic diseases or are allergic constitution (such as allergic to two or more drugs, food or pollen), the investigator judges that the safety of subjects may be compromised; 14. Having a history of drug abuse or being tested positive for drug abuse duing baseline visit; 15. Those who smoked more than 5 cigarettes per day or equivalent amount of tobacco wihtin 3 months; 16. Alcoholics or those who drink frequently within 6 months before screening, or being tested positive for alcohol breath test during baseline visit; 17. Those whose vital signs are abnormal (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or whose physical examination, electrocardiogram, and laboratory examination are abnormal and have clinical significance (According to the judgment of the clinical research doctor); 18. Pregnant or lactating women; 19. Female subjects who have childbirth or egg donation plan from the screening period to 6 months after the end of the clinical trial and disagree to take effective physical contraceptive measures, and male subjects who have birth or sperm donation from the screening period to 6 months after the end of the clinical trial and disagree to take effective physical contraceptive measures; 20. Subjects may not be able to complete the trial for other reasons or those the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation indicators (adverse events, laboratory examinations, vital signs, electrocardiogram examinations, physical examinations, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: Cmax, AUC0-t, AUC0-8, t1/2, Vd, CL, MRT0-t, MRT0-8 ect;Anti-drug Antibody, ADA;Anti-drug Antibody, ADA;Expression of type I IFN gene transcription level; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital of Central South University
Outcome results
None listed