Atopic Dermatitis
Conditions
Interventions
Group 1:GR1802 injection/placebo 75mg
Group 2:GR1802 injection/placebo 150mg
Group 3:GR1802 injection/placebo 300mg
Group 4:GR1802 injection/placebo 600mg
Group 5:GR1802 injection/placebo 900mg
Sponsors
Phase I Clinical Research Center, Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years(including 18 years old and 45 years old), both male and female; 2. BMI (body mass index) is 19.0-28.0 kg/m2 (including 19.0 and 28.0kg/m2), the weight of male subjects is >=50.0kg, and the weight of female subjects is >=45.0kg; 3. Female subjects have no childbirth or egg donation plan within 6 months from the screening period to the end of administration and voluntarily take effective physical contraceptive measures, and male subjects have no fertility within 6 months from the screening period to the end of administration Or plan to donate sperm and voluntarily take effective physical contraceptive measures; 4. According to the screening period physical examination, vital signs, electrocardiogram, clinical laboratory examination and other auxiliary examination results, combined with the previous medical history, the researcher judges that all the examination results are normal or abnormal and have no clinical significance; 5. Able to understand and comply with the requirements of the clinical program, voluntarily participate in clinical trials, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. There is an active infection or medical history; 2. Those with a history of active tuberculosis, or active tuberculosis at the time of screening or a positive tuberculosis laboratory test result at the time of screening; 3. Have a history of serious herpes virus infection, such as: herpes encephalitis, ocular herpes, disseminated herpes, etc.; 4. Those 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; 5. People with autoimmune diseases, such as dry eye, systemic lupus erythematosus, etc.; 6. Those who have conjunctivitis within 4 weeks before screening; 7. Those with a history of malignant tumors; 8. Past or present suffering from neuropsychiatric diseases; 9. Upon questioning, those 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; 10. Those 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; 11. Those who have received live/attenuated vaccination within 4 weeks before screening or plan to receive live/attenuated vaccination during the trial period; 12. Upon questioning, it is suspected or confirmed to be allergic to experimental drugs (including excipients, similar drugs), or suffering from severe allergic diseases or allergic physiques (such as allergies to two or more drugs, food or pollen), after research The judgement of the subject may damage the safety of the subject; 13. Those who have a history of drug abuse or drug abuse, or those who have a positive urine drug screening; 14. People who smoked more than 5 cigarettes or equivalent amount of tobacco per day within 3 months; 15. People who drank more than 28 units of alcohol per week within 3 months or tested positive for alcohol; 16. There are 12-lead ECG abnormalities considered by the investigator to be clinically significant at the time of screening; 17. When screening, ALT or AST>1.5N (upper limit of normal value), Cr>N (upper limit of normal value); 18. Those who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), HIV antibody screening (HIV), and anti-Treponema pallidum antibody (TPPA) during screening; 19. Subjects' understanding, communication and cooperation are not enough to guarantee that the research will be carried out according to the plan; 20. Other reasons why the researcher thinks it is inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation indicators (adverse events, laboratory examinations, vital signs, electrocardiogram examinations, physical examinations, etc; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters;Immunogenicity index; | — |
Countries
china
Contacts
Public ContactZhang Jing; Cao Guoying
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed