Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects

The Single-Dose Tolerability and PK/PD Study of Recombinant (Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Healthy Subjects

This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.

Inclusion Criteria:

• 18 years to 45 years,Healthy male and female subjects.in the same dose group,the age difference between in 10 years
• At least 50kg weight,BMI between 19 and 25kg/m2
• No tobacco, alcohol and other bad habits
• No history of drug allergy and biological agents allergy and other allergies
• Not used biological agents and other drugs within three months before participated in this test
• Not participated in other test or donated blood within three months before participated in this test
• The medical history、physical examination、laboratory examination is normal or slightly abnormal
• Subjects can obey the clinical trial protocol
• Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily.

Exclusion Criteria:

• History of severe system disease(especially with the spleen swelling, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia history)
• History of drug allergy and biological agents allergy and other allergies
• Subjects have used any long discharge period drugs will affect the present study within 3 months or are using drugs now
• Subjects not to take effective contraceptive measures or have a family planning within one year， Pregnancy or nursing women
• Subjects accepted major surgery 4 weeks before drug administration
• Subjects vaccinated live vaccine 3 months before drug administration
• Subjects with the history of drug abuse 5 years before drug administration
• As the subjects participated 3 times or more than 3 times drug clinical trials within 1 year or as the subjects participated any drug clinical trial or donated blood within 3 months
• Clinical and laboratory examination results is abnormal and have clinical significance
• Subjects with poor compliance or have any unfavorable factors to participate in this test
• Subjects can not complete the research
• The researchers and their family members.