A Randomized, Open-label, Single-dose, Dose-escalation, Self-controlled Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YPEG-Filgrastim in Cancer Patients Receiving Chemotherapy
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.
Shi Yuankai, Ph.D
Cancer Institute and Hospital, CAMS
China: Food and Drug Administration