Ankylosing spondylitis, rheumatoid arthritis, psoriasis
Conditions
Interventions
HS016:subcutaneous injection of HS016
Humira:subcutaneous injection of Humira
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Had to be able and willing to give written informed consent and to comply with the requirements of the study protocol; 2. Healthy male subjects between the ages of 18 and 45 years, inclusive; 3. Body Mass Index (BMI) between 20.0 to 25 kg/m2, inclusive; and a total body weight between 50-70 kg, inclusive; 4. During the trial period, the subjects or his partner used appropriate and effective contraceptive measures, such as abstinence, oral contraceptives, intrauterine devices, and dual barrier methods (such as condoms and contraceptive diaphragms).
Exclusion criteria
Exclusion criteria: 1. Evidence of clinically significant psychiatric, pulmonary, cardiovascular, gastrointestinal, urinary, reproductive, hematological, endocrine, neurologic and other systemic disease; 2. Factors of severe bleeding that affects venous blood collection; 3. Subjects with skin diseases or other diseases that affect subcutaneous injection; 4. History of malignant cancer; 5. Subjects with any known infections of active bacteria, viruses, fungi, parasitic infections or other infections or requiring antibiotic treatment or hospitalization within 4 weeks prior to enrollment; or subjects with the following symptoms: fever, night sweats, chills; weight loss; Feeling tired; muscle pain; coughing, shortness of breath, blood in the sputum; diarrhea or stomach pain; urinating sensation or frequent urination more than normal; red, hot skin or body acne; 6. Subjects have undergone surgery within two months prior to the signing of the informed consent form; 7. Alcoholics or subjects regularly drink alcohol within 3 months before the test, i.e., drinking more than 14 units of alcohol per week (14 bottles of 360mL beer or 630mL alcohol with 40% spirits or 2100mL wine), subjects with positive alcohol breath test results; 8. Subjects used soft drugs (such as marijuana) three months before signing the informed consent or subjects took hard drugs (such as cocaine, phencyclidine, etc.) one year before the test; those who are positive for drug abuse test (cocaine, Cannabis, morphine, amphetamine, methamphetamine, phencyclidine, benzodiazepines, barbiturates, methadone and tricyclic antidepressants; 9. Smokers or subjects had the average daily smoking volume of more than 5 within 3 months before the signing of the informed consent form, and subjects with positive smoke test results; 10. Subjects with a history of drug or food allergies, or have special dietary requirements, and cannot follow a uniform diet or a history of specific allergies (asthma, rubella, eczema dermatitis); Subjects allergy to any known ingredients or latex (contains in the syringe needle cover) of test drugs; 11. Subjects drink excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; 12. Received any medical treatment (including prescription drugs, over-the-counter drugs, biological products, proprietary Chinese medicines, vitamins, dietary supplements, etc.) and health supplements within 14 days prior to the signing of the informed consent form; 13. The use of traditional Chinese medicines (excluding proprietary Chinese medicines) and health supplements is prohibited during the trial; 14. Have a blood donation history within 3 months prior to the signing of the informed consent form, or plan to donate blood during the trial period; 15. Any biologic drug will be received within 3 months of administration of the test drug or will receive monoclonal antibody drug within 9 months; 16. Sperm cannot be donated within 6 months after administration of the test drug; 17. Surgery is planned during the trial (including cosmetic surgery, dental surgery, and oral surgery); 18. Plan to participate in strenuous exercise during the trial, including physical contact or collisional movements. 19. Anti-drug antibodies (HAHAs) tested positive; 20. Subjects participated in other clinical trials within 3 months prior to the signing of the informed consent form. 21. Subjects have received any vaccines 6 months prior to the signing of the informed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactJing Zhang
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed