Chemotherapy-induced Neutropenia
Conditions
Brief summary
This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.
Interventions
BIOLOGICALGW003
single SC injection
Sponsors
Jiangsu T-Mab Biopharma Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to day 21 | To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of subjects with Anti-GW003 antibody | up to 6 months after the trial | 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. |
| 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 | — |
Countries
China
Outcome results
None listed