Malignant tumors
Conditions
Interventions
Candidates drug group:LY01015 0.3 mg/kg IV infusion for 30±3min
Reference drug group:Ondivololol 0.3 mg/kg IV infusion for 30±3min
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Volunteers voluntarily sign a written informed consent form; 2. Men aged 18-45 (including 18 and 45); 3. 50.0kg<=body weight<=90.0kg and 19.0kg/m2<=body mass index (BMI)<=26.0 kg/m2.
Exclusion criteria
Exclusion criteria: 1. presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: rheumatoid arthritis, ankylosing spondylitis, autoimmune hemolytic anemia, interstitial pneumonia, uveitis, inflammatory bowel disease, autoimmune hepatitis, autoimmune pituitaryitis, glomerulonephritis, hyperthyroidism or decreased thyroid function, etc.); 2. known history or clinical presentation of suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymphatic tuberculosis, tuberculous pleurisy, etc.); 3. persons with any previous or current clinically serious disease of the circulatory, endocrine, nervous, digestive, respiratory, genitourinary, hematological, immunological, psychiatric and metabolic abnormalities or any other disease that can interfere with the test results; 4. a history of allergy to drugs, food or other substances; 5. a history of acute infection within 2 weeks prior to screening; 6. Subjects who have had an opportunistic infection within 6 months prior to screening (e.g., active cytomegalovirus, Pneumocystis carinii, Histoplasma capsulatum, Aspergillus, Mycobacterium, etc. infections); 7. subjects who have had a novel coronavirus or herpes zoster virus infection within 6 months prior to screening 8. who have undergone surgical procedures within 4 weeks prior to screening or who are scheduled to undergo surgical procedures during the study period; 9. those who have taken any medication or supplements (including herbal medicines) within 14 days prior to the study drug infusion; 10. have used any drug that inhibits or induces hepatic metabolism of the drug within 30 days prior to the study drug infusion (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative (hypnotics, verapamil, fluoroquinolones, antihistamines); 11. those who have used any biologic or received a live viral vaccine within 3 months prior to study drug infusion, or have used any monoclonal antibody within 12 months, or previous use of PD-1/PD-L1 drugs 12. Those who have participated in any clinical trial and taken any clinical trial drug within 3 months prior to screening; 13. those who have donated blood or lost a significant amount of blood (=200 mL), received a transfusion or used blood products within 3 months prior to screening; 14. volunteers who are unable to use one or more non-pharmaceutical contraceptive measures during the trial 15. those who are positive for any one of hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus antibody (HCV-Ab), anti-human immunodeficiency virus antigen antibody (Anti-HIV) and anti-syphilis spirochete specific antibody (TP-Ab); 16. Those who have a history of acupuncture or blood sickness; 17. Those who have special dietary requirements and cannot follow a uniform diet; 18. Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day; 19. smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to screening or those who could not stop using any tobacco-based products during the trial; 20. alcoholics or regular drinkers in the 6 months prior to screening, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine) or unable to stop using any alcohol-containing products dur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| physical examination;vital signs;laboratory test;12-lead ECG;adverse event; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed