Arthritis, pain, familial adenomatous polyposis
Conditions
Interventions
RMX1002:placebo
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. aged 18~55 years old; 2. body mass index (BMI, weight (kg)/height 2 (m2)) is 18~26 kg/m2 (including critical value); 3. Subjects will not plan pregnancy for the next 6 months and take effective contraceptive measures voluntarily; 4. vital signs, physical examination, laboratory examination, 12-lead electrocardiogram and chest X-ray examination showed no abnormal or abnormal clinical significance of the indicators; 5. subjects have no cardiovascular, liver, kidney, gastrointestinal, respiratory, blood and lymphatic, endocrine, immune, mental and neurological diseases or medical history; 6. The subject is fully aware of the purpose, nature, method and possible adverse reactions of the study, volunteers as subjects, and sign informed consent; 7. be able to communicate with the researchers and complete the test according to the plan.
Exclusion criteria
Exclusion criteria: 1. Screening or baseline 12-lead ECGs (ECGs) abnormalities, including QTc (QTcB) >450 ms, or heart rate >100 BPM, or QRS >120 ms, or PR >200 ms; 2. Human immunodeficiency virus antibody positive, or hepatitis b surface antigen positive, or hepatitis c antibody positive, or syphilis helix antibody positive; 3. Screening or baseline blood HCG? 5 mIU/mL, or female subjects in lactation. 4. Allergic or allergic reactions to drugs or compounds similar to structures or mechanisms. 5. Oral contraceptives or hormone replacement therapy were routinely used within 30 days of administration. 6. Use any prescription, over-the-counter or herbal medicine, especially aspirin and other NSAIDs drugs, within 14 days before the drug is administered. 7. Ingested foods or beverages (such as grapefruit, grapefruit juice, etc.) that can induce or inhibit liver metabolic enzymes within 7 days before administration. 8. Give medicine to finish the last 2 days before the pharmacokinetic blood samples during the intake any contain caffeine or after metabolism or xanthine food or drinks (such as coffee, tea, chocolate, cola, etc.) 9. Screening period/baseline urine drug test positive. 10. In the first 3 months of screening, the daily smoking rate was greater than 5 or habitual use of nicotine products. 11. In the first 6 months of the screening, alcohol consumption was greater than 14 units per week, or alcohol products were taken within 2 days before the drug delivery, or the screening period/baseline alcohol breath test was positive. 12. Patients who have had a major clinical disease or major surgical operation within the first 4 weeks of the administration or are expected to undergo major surgery during the trial period. 13. Participated in other clinical trials of drugs within 3 months prior to administration. 14. Blood donation or blood loss of more than 400 mL or received blood transfusion during the first 3 months of screening; Or more than 200 mL of blood donation or blood loss within 1 month before screening. 15. Failure to comply with test requirements (e.g. diet, tobacco and alcohol restriction) during the trial period. 16. It is difficult to take blood from the vein: it cannot tolerate venous puncture. 17. Any other researcher will judge any situation that is inappropriate to participate in the test. 18. An employee or relative of the bid unit or test center.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Countries
China
Contacts
Public ContactSHI Runcheng
Hangzhou RMX Biopharma Co.,Ltd
Outcome results
None listed