Malignant tumor
Conditions
Interventions
Pre-test - Carrilizumab (Old process):A single intravenous administration of 20 mg was performed, and 12 subjects were randomly divided into 1:1 groups to receive carrilizumab (old process) and carril
Pre-test - Carrelizumab (New process):A single intravenous administration of 20 mg was performed, and 12 subjects were randomly divided into 1:1 groups to receive carrilizumab (old process) and carril
Formal Test - Design Test Preparation (T):Test preparation (T) was a new process of carrilizumab
The reference preparation (R) was the old process carrilizumab. Using a single intravenous administration of 20 mg, 106 healthy male subjects were randomly divided into 1:1 groups to receive carrilizu
Official Test - Reference Preparation (R):Test preparation (T) was a new process of carrilizumab
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to enter the study: 1) Male =18 years old; 2) Weight =50 kg, Body Mass Index (BMI) of 19.0~28.0 kg/m2 (including both ends of the value); 3) The subject agrees to use a reliable contraceptive method for himself or his partner during the study period and for 4 months after the study drug infusion (see Appendix 1 for details); Fully understand the purpose of the test, the pharmacological action and possible adverse reactions of the drug under study; And comply with the test procedure, voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: Subjects will not be admitted to the study if they meet any of the following criteria: 1) Patients with a history of chronic diseases of the liver, kidney, cardiovascular, neurological/psychiatric, digestive tract, respiratory, urinary, endocrine and other systems; 2) Patients with a history of autoimmune diseases; 3) Regular drinkers who consumed an average of more than 15g of alcohol per day (equivalent to 145 mL of wine, 450 mL of beer or 43 mL of 40% alcohol liquor) in the six months prior to the trial; 4) Upon inquiry, people suspected or confirmed to be allergic or have had severe drug or food allergic reactions in the past, have a clear history of allergy and/or are allergic to the study drug or its ingredients; 5) Use of any drug (including Chinese medicine and vitamins) within 2 weeks prior to screening, or 5 half-lives of drugs less than the test dosing date of the last dosing, whichever is older; 6) Those who have used anti-PD-1 /PD-L1 drugs in the past; 7) Participants who had participated in other interventional clinical trials within 3 months before screening; 8) Those who have lost blood, donated blood or received transfusions of any blood product =400 ml in the 3 months prior to screening; 9) Those who underwent major surgery or were hospitalized for illness within 3 months before screening; 10) Those who had received live vaccine within 6 months prior to screening or expected to receive live vaccine during study participation; 11) Those with a history of drug abuse or positive drug screening results within 12 months prior to screening; 12) Patients with abnormal vital signs, physical examination and laboratory examination during the screening period and judged by the study doctor to be clinically significant (Note: Patients with abnormal signs and judged by the study doctor to be clinically significant can also be enrolled if they are within the normal range after re-examination); 13) Patients with abnormal ECG during the screening period (such as QTcF=450ms, shortened or prolonged PR interval, grade II and III atrioventricular block, pre-excitation syndrome, etc.) and judged by the study doctor to be clinically significant; 14) Patients with abnormal chest radiographs (anterior and lateral) or lung CT during the screening period and judged by the study doctor to be clinically significant; 15) Have a history of fainting needles and fainting blood; Or poor vascular conditions, can not keep buried needles or can not tolerate venous puncture blood collection; Participants considered unsuitable for this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Emergent Adverse Event;Serious Adverse Event;Area under the blood concentration-time curve of carrilizumab for new and old processes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inter-individual coefficient of variation of AUC0-8;Cmax;AUC0-t;Tmax;t1/2;CL;Vss;Anti-drug Antibody;Neutralizing Antibody;Adverse event; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed