Moderate to severe plaque psoriasis?ankylosing spondylitis in adults
Conditions
Interventions
QX002N injection,Placebo:
Sponsors
Jiangsu Qyuns Therapeutics Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. When signing the informed consent, healthy adults aged 18-50 (including both ends) years old; 2. Male subjects weighed =more than 50 kg and female subjects weighed =more than 45 kg. Body mass index (BMI = weight/height square (kg/m2)) within the ranged from 18 to 28 kg/m2 (including both ends). 3. Physical examination, vital signs normal or vital signs abnormal have no clinical significance 4. Agree to adopt effective contraceptive measures voluntarily and without family planning during the trial period and within 6 months after the end of the trial. See Appendix 5 for specific contraceptive measures. 5. Subjects fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as subjects, and sign the informed consent. 6. Be able to complete the test according to the requirements of the scheme.
Exclusion criteria
Exclusion criteria: 1.Those with immune diseases and a history of disease; 2. Anaphylactic constitution (allergic to a variety of drugs and foods) or a person who, as judged by the researcher, may be allergic to any component of a drug or drug under studyHave a known history of hypersensitivity to any medicine or food ,or allegy to the test articledrug or any of the excipient of the test articledrugss. 3. Drug abusers who had a history of drug abuse in the past five years or used drugs three months before the trial 4. Positive screeners for urinary drug abuse 5. These ones should be excluded who two-and-a-half pairs of hepatitis B (HBsAg negative but if satisfying HBsAb negative, HBcAb positive, then need to do HBV-DNA quantitative examination), hepatitis C antibody, Treponema pallidum antibody, HIV antibody positive 6. Systemic or local infections occur within 2 months before screening, such as the risk of sepsis and/or known active inflammation. 7. Four or more upper respiratory tract infections occurred within 6 months before screening 8. People with a history of active tuberculosis or screening for presence of active or latent tuberculosis infections at screening 9. blood donation=400 mL within 3 months before screening, or those who have severe blood loss and blood loss is equivalent to 400 mL, or who have undergone blood transfusion within 8 weeks 10. Four weeks before screening, or those who plan to vaccinate live (attenuated) vaccines in the course of the trial 11. Any prescription or Chinese herbal medicines were used within 4 weeks before the start of the trial, and over-the-counter or dietary supplements (including vitamins, calcium supplements, etc.) were used within 2 weeks 12.Clinical laboratory examinations abnormalities have clinical significance, or other clinical findings show clinical significance in the following diseases (including but not limited to nervous system, cardiovascular system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, skeletal system diseases, inflammatory bowel disease) 13. Smoking more than 5 cigarettes per day or habitual use of nicotine-containing products in the first three months of screening, and drinking more than 14 units of alcohol per week in the first six months of screening (1 unit alcohol = 360 mL beer or 45 mL alcohol content of 40% spirits or 150 mL wine) 14. Those who have taken alcoholic products two days before administration 15. Female subjects during pregnancy or lactation 16. The electrocardiogram abnormal has clinical significance or the QTc interval of male or female subjects is > 450ms. 17. Researchers believe that any other situations that may affect the subjects signing the informed consent or following the test program, or the participants' taking part in the trial may affect the test results or their own safety 18. Those who have participated in clinical trials of any drug or medical device within 3 months before screening 19. There are acute diseases or concomitant medication from screening stage to pre-medication study 20. There are systemic diseases of clinical significance such as hypertension, coronary heart disease, diabetes and history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index;Immunogenicity index; | — |
Countries
China
Contacts
Public ContactDing Yanhua
the First Hospital of Jilin University
Outcome results
None listed