Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants
Status:
Recruiting
Trial end date:
2022-03-22
Target enrollment:
Participant gender:
Summary
This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple
ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to
investigate whether CORT125236 ameliorates the effects of prednisone on various
pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially
provided that this is justified by the pharmacokinetic (PK) and safety data obtained from
completed cohorts. The first MAD cohort will not start until data are available from at least
3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3
can be made at any point after completion of 3 SAD levels, and will be based on achieving
sufficiently high plasma CORT125236 exposure in Part 1 of the study.