Study design
RA, SAD
This was a randomized (within-group), double-blind, placebo-controlled, SAD, phase Ia study including patients with RA from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Beijing Hospital. The trial was registered in the Centre for Drug Evaluation of China Food and Drug Administration (CFDA) (ChiCTR: CTR20170306). The trial was conducted in compliance with the Declaration of Helsinki, as well as with Good Clinical Practice and applicable regulatory requirements. The protocol was approved by the ethic committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Beijing Hospital (site 1 approval number 2017BJYYEC-019-02/site 2 approval number: HS2017014/NMPA approval number: 2016L10654) before study initiation and written informed consent was obtained by a delegated rheumatologist from all study patients before performing any study procedure.