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

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

Official Title
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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

Conditions
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Chemotherapy-induced Neutropenia

Intervention / Treatment
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* Biological: GW003


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ic-GW003 150ug/kg 4-8subjects<br>Biological/Vaccine:GW003 freeze-dried powder single SC injection | Biological: GW003<br>* single SC injection<br>|
| Experimental: Ic-GW003 300ug/kg 6-8subjects<br>Biological/Vaccine:GW003 freeze-dried powder single SC injection | Biological: GW003<br>* single SC injection<br>|
| Experimental: Ic-GW003 500ug/kg 6-8subjects<br>Biological/Vaccine:GW003 freeze-dried powder single SC injection | Biological: GW003<br>* single SC injection<br>|
| Experimental: Ic-GW003 650ug/kg 6-8subjects<br>Biological/Vaccine:GW003 freeze-dried powder single SC injection | Biological: GW003<br>* single SC injection<br>|
| Experimental: Ic-GW003 850ug/kg 6-8subjects<br>Biological/Vaccine:GW003 freeze-dried powder single SC injection | Biological: GW003<br>* single SC injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects. | up to day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of subjects with Anti-GW003 antibody | anti-GW003 was detected pre-dose and at the last visit,if there exist positive anti-GW003 antibody, another detected should be conducted 6 months after the trial. | up to 6 months after the trial | 
| half-life(consist of distribution and elimination half-life) for GW003 |  | up to day 14 | 
| area under the concentration-time curve(AUC) for GW003 |  | up to day 14 |