The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections. To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration
This experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics. Breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study. The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses. Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
Number of adverse events
Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
Time frame: 14 days
AUC
AUC after single and multiple dose of rHSA/GCSF
Time frame: 14 days
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multiple injection-1.8mg
multiple injection-2.1mg
multiple injection-2.4mg