Study design
This was a randomized, double-blind, placebo-controlled, dose-escalation phase 1 trial of SHR-1222 in women with POP conducted at 11 sites in China (NCT04435158). Subject participation consisted of a 30-d screening period, 24-week treatment period, and 57-d treatment-free follow-up period.The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization/Good Clinical Practice Guidelines as well as local regulatory requirements. The study protocol and amendments were approved by the ethics committees of all participating centers, and all subjects provided written informed consent before enrolment. This study was registered with ClinicalTrials.gov (NCT04435158).