Phase Ⅰ Study to Evaluate the Safety and Tolerability of Using F520
Status:
Recruiting
Trial end date:
2022-10-08
Target enrollment:
Participant gender:
Summary
Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code:
F520) is joint developed by Shandong New Time Pharmaceutical Co., LTD., it is the
reorganization of deoxyribonucleic acid (DNA) technology in the Chinese hamster ovary (CHO)
cells express system expressed in a immunoglobulin G1 (IgG1) kappa type single resistance to
predominate. F520 had the different new amino acid sequence and molecular structure compared
with two marketed PD-1 monoclonal antibody injection and got the approval of China Food and
Drug Administration (CFDA) for clinical trial.Pharmaceutical research indicated F520 cell
strain had security source, production process is stable, quality can control, preparation
stability, has good compatibility with packaging materials, it has the condition of
industrialization, can prepare investigational medicinal product with safety, effective, and
controlled quality for clinical research.Pharmacodynamics study show the targets and
mechanisms of F520is clear, tumor suppression effect is obvious.Toxicology studies show this
product in high doses with low toxic, and the toxic is reversible, the most common toxicity
is specific to the drug action mechanism.