Study design
MAY
This was a randomized, open-label, placebo-controlled, phase 1b study (Clinical Trial Registration Number: NCT05470829; Chinese Clinical Trial Registration Number: CTR20210686), which was conducted at the Phase I Clinical Research Center, The First Hospital of Jilin University (Jilin, China), during the period from May to November of 2021. In order to minimize the safety risk of Canocapavir, an adaptive ascending dosing strategy was adopted for Canocapavir treatment in this study. The second and third assigned doses were initiated only after the safety data from the previous dose was reviewed and determined to be safe by the Principal Investigator and the Sponsor on day 8 postdosing (post drug administration days). Canocapavir was administered at the Clinical Research Center on days 1–8 and day 28 and at home on days 9–27 under the same conditions (fixed administration time and fasting condition). Patients were required to visit the facility for follow-up on days 15, 22, 27, 43 ± 1, and 57 ± 2 postdosing. The study protocol and informed consent forms were prepared according to the principles of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board of the First Hospital of Jilin University (approval number: 20Y201-006). All recruited patients provided written informed consent before participating in any study-related procedures.