Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

Summary

This is a first in human (FIH), single-centre, double blind, randomised, cross-over, SAD followed by a MAD study of Inzomelid. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of Inzomelid in healthy adult participants and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of Inzomelid in adult patients with CAPS. Oversight will be provided by a safety monitoring committee (SMC) comprised of the Investigator, the Sponsor's Medical Monitor and an Independent Medical Monitor.

Timeline

Start

2019-07-16

Primary completion

2020-03-23

Completion

2020-03-23

Drugs

Indications

No indication recorded.