drugset / Trial / NCT04086602

Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

NCT04086602 ↗

Phase 1 Completed 64 enrolled Inflazome UK Ltd
RandomizedParallel-groupDouble-blindOther

Summary

This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD followed by a MAD study of IZD334 conducted in healthy adult participants as well as an open-label cohort in adult patients with CAPS. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of IZD334 in healthy adult participants, and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of IZD334 in adult patients with CAPS.

Timeline

Start
2019-09-13
Primary completion
2020-02-04
Completion
2020-02-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Selnoflast Small molecule — Oral