A FIH Study to Investigate the Safety, Tolerability and PK of P218

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.

Timeline

Start

2016-08-24

Primary completion

2017-12-04

Completion

2017-12-04

Drugs

Indications