leukopenia
Conditions
Interventions
2:PEG-G-CSF
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: ?Healthy male and female volunteers, 18 to 55 years of age;?Body mass index (BMI) 19 - 24 kg/m2 inclusive;?Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests,including blood routine?urine routine, routine stool test, renal function and liver function, blood glucose, HBV, HCV, HIV, eleclxolytes, thyroid function, humoral immunity, ECG, women in the child-bearing age should detected the urine pregnancy;?The subjects are free from diseases;?No smoking, no drinking;?In the opinion of the principal investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed. Willing to use an effective method of contraception (condoms, anatomical sterility) throughout the study period.
Exclusion criteria
Exclusion criteria: ?Clinically significant abnormalities in laboratory test results, vital signs or ECGs; ?Any confirmed significant allergic reactions against any drug, or multiple allergies, a medical history that includes any chronic pulmonary conditions; ?Took any medications (including traditional Chinese medicine) during the two weeks prior to study conduct; ?Participation in an investigational drug study within 30 days prior to screening; ?Donate blood or drug study that need blood collection 3 months prior to drug administration; ?Used drugs that are known for a certain organs damage 3 months prior to drug administration; ?Heavy drinking and smoking, or drug abuse; ?Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;pharmacodynamic; | — |
Countries
China
Contacts
Public ContactLi Zheng
Institute of Drug Clinical Trial? GCP Center, West China Hospital, Sichuan University
Outcome results
None listed