A FIH Study to Investigate the Safety, Tolerability and PK of P218
Status:
Completed
Trial end date:
2017-12-04
Target enrollment:
Participant gender:
Summary
The First in Human (FIH) study is separated into two parts:
- The first part is a Single Ascending Dose (SAD), double-blinded, randomized and
placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug).
- The second part is a food effect cohort with an open-labelled, randomized fed/fasted
cross-over design.
The main objectives of the study are to confirm safety, tolerability and Pharmacokinetics
(PK) of P218 in healthy volunteers.