Adult subjects with moderate to severe plaque psoriasis
Conditions
Interventions
QX004N group:QX004N Injection
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.When signing the informed consent form, healthy adults aged 18-45 (including both ends) years old; 2.The weight of male subjects are between 50 kg and 100kg, and the weight of female subjects are between 45 kg and 100kg (including both ends); Body mass index (BMI = weight/height square (kg/m2)) are between 18 and 28 kg/m2 (including both ends); 3.After comprehensive examination including general physical examination and laboratory examination, 12 lead ECG, abdominal ultrasound and chest X-ray examination showed no abnormality or abnormality but no clinical significance; 4.Agree to take effective contraceptive measures voluntarily during the trial and within 6 months after the end of the trial; 5.Able to read and fully understand the perspective, nature, method and possible adverse reactions of study and willing to sign the informed consent form (ICF); 6.Those who can complete the study according to the clinical study protocol.
Exclusion criteria
Exclusion criteria: 1.Abnormal immune system function disease and history before screening; 2.Have a history of drug or other allergy and the risk of participating in this study was higher , or may be allergic to the study drug or any component of the study drug according to the judgment of the researcher; 3.Those who have a history of drug abuse in the past five years or have used drugs three months before the test; or those who are positive in urine drug abuse after screening; 4.These ones with positive HBsAg during screening; or meet the following three conditions at the same time: anti-HBc positive, anti-HBs negative and HBV DNA results exceed the normal range; or HCV antibody, HCV core antigen positive; or HIV antigen/antibody positive; or Treponema pallidum antibody positive (RPR should be added to Treponema pallidum antibody screening positive, if RPR is negative, you can be included in the study) ; 5.Those with infection (including chronic or local infection) in the past 7 days, those with a history of recurrent infection and underlying diseases prone to infection; 6.Those with a history of active tuberculosis, or those with active or latent tuberculosis infection during screening; 7.Those with blood donation or lose>=400 ml within 4 weeks before screening, or received blood transfusion within 8 weeks; 8.Those who plan to receive live (attenuated) vaccine 4 weeks before screening or during the trial; 9.Used any prescription medicine or Chinese herbal medicine within 4 weeks before administration, or used over-the-counter or dietary supplements (including vitamin and calcium supplements) within 2 weeks; 10.Existing abnormal or disease, and investigators believe it has clinical significance or influences the research, including but not limited to nervous system, cardiovascular system, kidney, liver, gastrointestinal tract, respiratory system, blood system, metabolism, endocrine, tumor, lung, immune, mental or cardiovascular diseases; 11.Those who smoked more than 5 cigarettes per day or used nicotine containing products habitually within 3 months before screening; 12.Those who drunk 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 liquor or 150 ml of wine with 40% of alcohol content) or taken products containing alcohol 2 days before administration; 13.Those who have participated in clinical trials of any drug or medical device within 3 months before screening; 14.Female subjects with positive pregnancy test or during lactation; 15.In the opinion of the investigator, any other situation that may affect the informed consent of the subjects or the compliance with the test scheme, or the subjects' participation in the test may affect the test results or their own safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic;Immunogenicity; | — |
Countries
China
Contacts
Public ContactDing Yanhua
the First Hospital of Jilin University
Outcome results
None listed