Psoriasis
Conditions
Interventions
Experimental group -0.3mg/kg dose:Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 0.3mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the i
Experimental group -0.9mg/kg dose:Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 0.9mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the i
Experimental group -1.8mg/kg dose:Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 1.8mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the i
Experimental group -3.0mg/kg dose:Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 3.0mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the i
Experimental group -4.5mg/kg dose:Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 4.5mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the i
Experimental group -6.0mg/kg dose:Subjects were given intravenous injection of KYS202004A, the dosage and preparation: 6.0mg/kg KYS202004A injection was dissolved in 100 mL 5% glucose injection, the i
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in the study and obtain informed consent prior to any study-related evaluation; 2. Aged between 18 and 55 years (including the cut-off) at the time of the screening visit, male or female; 3. At the time of screening visit, the weight of male subjects should not be less than 50 kg and that of female subjects should not be less than 45 kg. Body mass index in the range of 19.0 ~ 26.0 kg/m^2 (including the critical value); 4.During screening and baseline visit, subjects were judged to be in good health (platelet count should not be lower than the lower limit of normal) according to previous medical history, vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, etc.; 5.The subject (including the partner) agrees to voluntarily take effective contraceptive measures from the date of signing the informed consent to 6 months after the administration of the drug; The blood pregnancy test for female subjects must be negative and non-lactating; No sperm or egg donation within 6 months after self-medication; 6.Be able to communicate well with the investigator and be willing to comply with visits, study treatments, laboratory tests, and other research-related procedures and requirements as specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Allergy to the investigational drug or its excipients, or a history of severe allergies (including any food allergies or drug allergies); 2. Any previous disease or physical condition such as major central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal disease, urinary system, autoimmune disease or tumor at the time of the screening visit, or any existing acute disease; 3. Previous history of moderate to severe congestive heart failure (grade III or IV on the New York Heart Association grading criteria); 4. Previous organ transplantation; 5. History of chronic or recurrent infectious diseases, or systemic infections caused by fungal, parasitic or fungal pathogens, or other opportunistic infections; 6. Known history of active or latent tuberculosis, or inadequately treated latent tuberculosis infection, or history of contact with tuberculosis patients; 7. Severe bone or joint infection within 6 months before screening, or serious infection within 3 months before screening (such as hospitalization for infection, or parenteral antibiotic treatment for infection), or herpes zoster virus infection within 3 months before screening; 8. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis C antibody (HCV-Ab), or positive for human immunodeficiency virus antibody (HIV-Ab), or positive for Treponema pallidum antibody (TP-Ab); 9. Presence of any acute infection, or with any signs or symptoms of infection; 10. Previous severe bleeding, or severe ulcers or fractures of skin wounds, surgical sites, trauma sites, mucous membranes that have not healed completely at the time of screening, or active gastroduodenal ulcers, intestinal obstruction, ulcerative colitis, esophageal and gastric varices, gastrointestinal perforation, or other bleeding risks within 6 months prior to screening; 11.12 Abnormal and clinically significant lead ECG, e.g., QTcF interval (Fridericia's correction) >450 ms for males and 470 ms for females> 12. Serum creatinine clearance (Ccr) < 90 mL/min (calculated according to the Cockcroft-Gault formula); 13. Known or suspected history of drug abuse (such as: morphine, methamphetamine, ketamine, methylenedioxyamphetamine, tetrahydrocannabinolic acid, etc.), or positive drug screening test at baseline; 14. Alcohol abuse within 1 year prior to screening (drinking more than 14 standard units per week, 1 standard unit containing 14 g of alcohol, such as 360 ml of 5% beer, 45 ml of 40% spirits, 120 ml of 12% wine), or the breath test value of alcohol in the baseline period is greater than the upper limit of normal; or unable to comply with the prohibition of alcohol consumption for the duration of the study; 15. Smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to comply with the smoking ban during the study; 16. Do not agree or cannot guarantee that you will not ingest any food or drink (such as coffee, tea, chocolate) that contains or produces caffeine or xanthine after being metabolized from 48 hours before the first dose of the trial to discharge; 17. Received a vaccine within 3 months prior to screening, or received any vaccine within 30 days prior to screening, or plans to receive any vaccine during the study; 18. Received any investigational drug treatment or participated in any drug/investigational device trial within 6 months prior to screening; 19. During the period from 14 days before dosing t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs ;Physical examination ;12-lead electrocardiogram;Plasma elimination half-value period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak concentration;Time to peak;Area under the plasma-drug concentration-time curve ;Plasma clearance;Apparent volume of distribution;Mean residence time;Incidence of anti-drug antibodies (ADA) after administration;TNF-a levels and changes from baseline;IL-17A levels and changes from baseline; | — |
Countries
China
Contacts
Public ContactMiao Liyan
The First Affiliated Hospital of Soochow University
Outcome results
None listed