Crohn's disease
Conditions
Interventions
Group A:QX004N injection
Group B:Placebo
Sponsors
Peking University Third Hospitol
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 18 to 60 (inclusive) when signing the ICFs; 2. Male subjects weigh at least 50 kg and no more than 100 kg inclusive, female subjects weigh at least 45 kg and no more than 100 kg inclusive; Have a body mass index between 18 and 27.9 kg/m2 inclusive [BMI=weight/height squared (kg/m2)]; 3. Subjects receive a comprehensive examination including general physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal color ultrasound examination, and anteroposterior chest radiograph, which is normal or abnormal but have no clinical significance; 4. Subjects agree to have no reproductive plan and voluntarily take effective contraceptive measures during the trial and within 6 months after the trial (see Appendix 3 for specific contraceptive measures); 5. The subjects fully understand the purpose, nature, methods, and possible adverse reactions of the trial, voluntarily become subjects, and sign the ICFs; 6. Subjects can complete the trial as required in the protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects who have a history of drug-related or other allergies and are considered by the investigator to be at high risk of participating in the study, or who are considered likely to be allergic to the study drug or any component of the study drug; 2. During screening, HBsAg is positive in the Hepatitis B serologic test, or meet all of the following three conditions: HBcAb is positive, HBsAg is negative and HBV DNA result is beyond the normal range, or hepatitis C antibody is positive, or HIV antigen/antibody is positive; (RPR should be added when syphilis seropositive antibody positive. if RPR is negative, the subject can be included in the group); 3. Subjects with a history of active TB, or those infected with active or latent TB at the screening; 4. Subjects who had a history of drug abuse in the past five years or had used drugs within three months prior to the trial or had a positive result of urine drug test; 5. Smoke more than 5 cigarettes a day or use nicotine-containing products habitually in the 3 months before screening; 6. 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; 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. 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; 11. Subjects with abnormal immune system function disease and history before screening; 12. 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; 13. At the screening or baseline, subjects who meet any of the following criteria and are considered by the investigator to have clinical significance: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or ?-glutamyltransferase (GGT) exceeds 1.5 times the upper limit of normal (ULN), or total bilirubin exceeds 1.5 times ULN, or lipase or amylase exceeds 1.5 times ULN; 14. At the screening or baseline, serum creatinine > 1.5 ULN, or glomerular filtration rate less than 80 mL/min; 15. At the screening or baseline, the urine occult blood test is positive and significantly considered by the investigators; 16.12-lead electrocardiogram, abdominal B-ultrasound and chest radiography are abnormal and have clinical significant, which includes the electrocardiogram did not meet the requirements: QTcF 140 mmHg or 90 mmHg or 100bpm or < 50bpm), the projects with the abnormal result should have at least one retest to confirm; 17. Subjects who have participated in clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Tolerance;Pharmacokinetic;Immunogenicity; | — |
Countries
China
Contacts
Public ContactLiu Dongyang
Peking University Third Hospital
Outcome results
None listed