A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects.

Ya-Nan LiuJie HuangCan GuoShuang YangLing YeShu-Ting WuXing-Fei ZhangXiao-Yan YangCui-Cui HanQi PeiLu HuangQing-Nan HeGuo-Ping Yang

Published in: Cancer chemotherapy and pharmacology (2020)

The study demonstrated the pharmacokinetic equivalence of QL1101 to Avastin®. QL1101 (3 mg/kg, iv) is safe and tolerable in healthy Chinese subjects. These data support the further clinical evaluation of QL1101 as a bevacizumab biosimilar.

Keyphrases

double blind
clinical trial
randomized controlled trial
machine learning
study protocol
big data
deep learning
placebo controlled
artificial intelligence
phase ii
phase iii