32
Participants
Start Date
February 5, 2021
Primary Completion Date
September 8, 2021
Study Completion Date
November 2, 2021
RBD1016
"Sentinel cohort design is used in each cohort: each cohort will be administered in two batches, the first 2 subjects will receive RBD1016 or placebo respectively, and safety assessment will be done on D8±1. After safety is confirmed through SRC assessment, the remaining 6 subjects will be randomly assigned to receive RBD1016 or placebo in a ratio of 5:1. SRC will assess the safety after all the subjects in each cohort complete the 28-day safety observation and the subjects may proceed to the next dose cohort with permission.~Only after all the subjects in the previous dose cohort have completed the safety assessment by SRC (observed for 28 days) may the next dose cohort be initiated with permission."
Placebo
the same as RBD1016
Scientia Clinical Research Ltd, Randwick
Suzhou Ribo Life Science Co. Ltd.
INDUSTRY