The tumor radiation and chemotherapy drugs
Conditions
Interventions
T:Subjects single test subcutaneously (2.7 x 108 iu (6 mg) : 0.6 mL/a)
R:Subjects single control subcutaneously (1.35 x 108 iu (3 mg) : 1.0 mL/a)
Sponsors
Phase I ClinicalTrial Laboratory of The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 45 years old male healthy subjects (including boundary value); 2) weight more than 50.0 kg (including boundary value), body mass index (BMI) of between 19.0 ~ 26.0 kg/m2 (including boundary value); 3) the participants voluntarily signed written informed consent; Subjects were able to make good communication and compliance with the researchers plan to complete the test
Exclusion criteria
Exclusion criteria: 1) before or are currently suffering from circulation system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities such as any clinical severe disease or any other disease which can interfere with the test results, or with the spleen, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia, or any other disease which can interfere with the test results or physiological condition; 2) there are experimental drugs (PEG - rhG CSF any ingredient or drug) of polyethylene glycol modified, food allergies or other substances; 3) test received within 4 weeks before surgery, or plan to have surgery during the study period; 4) test within 14 days before taking any medicines or health products (including Chinese herbal medicine); 5) test used within 30 days before any inhibition or induction of liver of drug metabolism drugs (such as: revulsant - barbital, carbamazepine, phenytoin, glucocorticoid, omeprazole;Inhibitors - SSRI antidepressants, cimetidine, diltiazem, large ring lactone class, nitro imidazoles, sedative hypnotics, verapamil, fluoroquinolone, antihistamines class); 6) test within three months before taking any drug or participated in any clinical trials drugs clinical subjects; 7) within 3 months prior to test blood donors; 8) subjects will not be used during the testing of one or more than one non-drug contraception; 9) do you have any special dietary requirements, cannot observe unified diet; 10) a day to drink too much coffee, tea and/or caffeinated beverages (8 cups and 1 cup = 250 mL); 11) 3 months before the tobacco or test daily smoking more than 5 pieces and test can't smoking during hospitalization period; 12) within 6 months prior to alcoholics or test often drinkers, that drinking more than 14 units of alcohol a week (1 = 45 mL 360 mL beer or alcohol content of 40% spirits or 150 mL wine); 13) 3 months before the drug abusers or test used soft drugs (such as marijuana) or test a year before taking hard drugs (such as cocaine, benzene ring has piperidine, etc.); 14) vital signs is unusual ( 90 mmHg systolic, diastolic blood pressure 90 mmHg.Heart rate 100 BPM) or physical examination, electrocardiogram (ecg) and laboratory abnormalities have clinical significance (with clinician determine accurate); 15) known to severe bleeding factors affecting venous blood; 16) used biological growth factors, including but not limited to rhG CSF and other restructuring granulocyte stimulating factor drugs;And the use of interferon, erythropoietin and intravenous immunoglobulin; 17) within a month before the screening or plan to test during the activity or attenuated vaccine, or suffering from infectious diseases such as chicken pox, mumps and measles patients; 18) researchers think doesn't fit into the group of subjects (such as unable to understand and comply with the test requirements, considering from safety doesn't fit into the group).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;PD ANC; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Phase I Clinical Trial Laboratory of The Third Xiangya Hospital of Central South University
Outcome results
None listed