None listed
Conditions
Interventions
R and T Group:sigle-dose
R and T group:3mg/kg,iv
Sponsors
Phase I clinical study room of The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 36 Years
Inclusion criteria
Inclusion criteria: 1) Male subjects aged 18-40 years; 2) The body weight is not less than 50 kg (including the boundary value), and the body mass index (BMI) is between 19 and 26 kg/m2 (including the boundary value); 3) agree to take effective contraceptive measures throughout the study period up to 6 months after completion of the drug (including but not limited to: hormonal contraception, or physical contraception, or abstinence); 4) Subjects voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) (Inquiry) Any person with a history of serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities may or may interfere with the test results. Any other disease; 2) (Inquiry) Have hereditary hemorrhage, thrombosis tendency, history of thrombosis (such as: cerebral thrombosis, history of arteriovenous thrombosis), or have a history of non-traumatic hemorrhage and take appropriate treatment, or there may be any other possible test Diseases with an increased risk of bleeding or thrombosis (eg, abnormal coagulopathy, thrombocytopenia, or INR > 1.5); 3) (Inquiry) Have a history of malignant tumors (including lymphoma, leukemia, skin cancer); 4) (Inquiry) Have a history of hypertension, or have had orthostatic hypotension, syncope; 5) (inquiry) Has a history of allergies to drugs, food or other substances; 6) (Inquiry) Those who have undergone surgery or fractures within 4 weeks prior to the trial, or who plan to undergo surgery during the study; 7) (Inquiry) Those who have taken any drug within 14 days before the test (including Chinese herbal medicine, except paracetamol); 8) (Inquiry) Any biological product or live virus vaccine was used within 3 months before the test, or any monoclonal antibody was used within 9 months, or bevacizumab or VEGF was used before the test. Targeted preparations (eg Aflibercept, Ranibizumab, Conbercept, etc.); 9) (Inquiry) Those who took any clinical trial drugs or participated in any drug clinical trial within 3 months before the trial; 10) (Inquiry) Blood donors within 3 months before the trial; 11) (inquiry) Has special requirements for diet and cannot follow the unified diet; 12) (Inquiry) Drinking excessive amounts of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250 mL) per day; 13) (Inquiry) Are smokers or more than 5 daily smokers in the first 3 months of the trial; 14) (Inquiry) For alcoholics or those who regularly drink alcohol within 6 months prior to the test, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) ); 15) (Inquiry) For drug abusers or soft drugs (such as marijuana) used 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 16) The ECG is abnormal and has clinical significance as judged by the investigator; 17) Those with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm); 18) Physical examination, laboratory examination, and imaging examination are clinically significant (subject to the judgment of the clinician); 19) Impaired liver function: ALT > 1.5 times upper limit of normal (ULN), AST > 1.5 times upper limit of normal (ULN); 20) Subjects may not be able to complete the study for other reasons or those the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum ADA;Serum Nab; | — |
Contacts
Public ContactGuoping Yang
Outcome results
None listed