Moderate to severe plaque psoriasis
Conditions
Interventions
Group 1:NVS451 fusion protein for injection 15 mg/37.5 mg/75 mg/150 mg//300 mg/450 mg single dose
Group 2:The NVS451 fusion protein placebo for injection was administered by subcutaneous abdominal injection by drawing a certain volume of drug solution with a syringe according to the prescribed dos
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 2) Able to complete the research according to the requirements of the test plan; 3) Subjects (including partners) voluntarily take effective contraceptive measures from screening to 6 months after the end of the trial drug administration. The specific contraceptive measures are shown in the appendix; 4) Male and female subjects aged 18 to 55 (including 18 and 55 years old); 5) The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18.0~28.0 kg/m2 (including the critical value); 6) Physical examination, normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1) Those who have undergone surgery within 6 months before screening or those who plan to undergo surgery during the trial; 2) Those who donated blood or lost more than 450 mL of blood within 3 months before screening, or who received blood transfusion or used blood products; 3) Allergic constitution (allergic to 2 or more substances), or known to be allergic to test drugs or excipients; 4) Those who smoked more than 5 cigarettes per day in the 3 months before screening; 5) History of drug and/or alcohol abuse within 6 months prior to screening, i.e. drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or not guaranteed to give up during the trial Alcoholic drinkers, or those with a positive breath test for alcohol; 6) Suffering from autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory myopathy, systemic sclerosis, etc.; 7) Serious infection (such as pneumonia, cellulitis) or herpes zoster virus infection, hospitalization, or intravenous antibiotics for infection occurred within 12 weeks before enrollment; any infection within 7 days before enrollment ( Including chronic or local infection such as local skin infection); 8) The number of upper respiratory tract infections = 4 times within 6 months before enrollment; 9) Those with clinical evidence of active tuberculosis or suspected of active tuberculosis, or those with previous evidence of active tuberculosis but not receiving appropriate treatment or lack of treatment records; or those with evidence of latent tuberculosis infection during screening; 10) Have taken any prescription drug, over-the-counter drug, any vitamin product or traditional Chinese medicine within 14 days before using the test drug; 11) Those who have received treatment with interleukin 17 or similar drugs within 3 months before using the test drug, or participated in other clinical trials; 12) Those who have a history of vaccination within 3 months before screening, or those who plan to receive live vaccines or live attenuated vaccines during clinical trials; 13) Those with difficulty in venous blood collection or fainting of needles and bleeding, and those who are difficult to perform subcutaneous injection; 14) Abnormal ECG has clinical significance; 15) Female subjects are breastfeeding or have a positive blood pregnancy result during the screening period or the test; 16) Clinically significant abnormalities in clinical laboratory examinations (including but not limited to blood ALT and/or AST>1.5×Upper limit of normal (ULN); serum creatinine>124 µmol/L in female subjects, serum creatinine in male subjects >141 µmol/L; platelet count 1.5×ULN), or other clinically significant following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve , blood, endocrine, tumor, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases), or chest X-ray results at screening showing clinically significant abnormalities, including but not limited to evidence of exposure to tuberculosis; 17) Persons with positive results of any one of the tests for qualitative hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen, human immunodeficiency virus [HIV] antigen and antibody test, and Treponema pallidum specific antibody test; 18) Acute disease occurs during the pre-study screening phase or before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) Characteristics;Immunogenicity; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed