Plaque psoriasis
Conditions
Interventions
Randomized parallel controlled trial:GR1501 Injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 to 65 years; 2. Body index(BMI)18-32 kg/m2; 3. Plaque psoriasis history =6 month; 4. Psoriasis body surface area(BSA)=10%; 5. The grade of psoriasis area and severity index(PASI)=12; 6. The poor treatment effect on patients with Moderate and severe plaque psoriasis; 7. Consent to participate in the research study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. At baseline or screening, patients with pustular psoriasis, erythroderma psoriasis and / or drip psoriasis; 2. Drug psoriasis on baseline; 3. Systemic therapy on the whole body within 4 weeks prior to the baseline; 4. Received any biological agents directly targeting IL-17; 5. Participate in other clinical trials within 3 months prior to the baseline; 6. Received live vaccine within 4 weeks prior to the baseline; 7. Patients with Active tuberculosis;8.Drug and biological agents allergies; 9. Received a major operation within 8 weeks prior to the baseline or study period; 10. Subjects with history of lymphoproliferative disease or with malignant tumor previously or concurrently; 11. Subjects with active infection previously or concurrently; 12. Subjects with hepatitis B surface antigen positivehepatitis C antibody positivehuman immunodeficiency virus (HIV) antibody positive or TPPA positive; 13. ECG abnormalities with clinical significance; 14. Unstable cardiovascular disease; 15. Hypertensive patients with unstable blood pressure; 16. Subjects with abnormal function of liver and kidney or blood routine abnormality; 17. Blood donation =400ml or blood lose =400ml within 4 weeks prior to the baseline; 18. women who have fertility refusal to adopt contraception from the screening period to the last time after the end of the drug delivery; 19. Pregnancy or lactation; 20. Subjects with smokehard-drinkingtake drugs and drug abuse; 21. Subjects with history or family history of severe psychosis; 22. Other subjects judged by the investigator to be ineligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| t1/2, Cmax, Tmax, AUC0-t, AUC0-8, AUCss, Cav, CL;Immunogenicity;PASI 75, PASI 90, sPGA "0" or "1"; | — |
Countries
China
Contacts
Public ContactJianzhong Zhang
Peking University People's Hospital
Outcome results
None listed