NCT04086602

Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of IZD334 in Healthy Adult Participants as Well as an Open-label Cohort to Confirm the Safety, Pharmacokinetics, and Pharmacodynamics in Adult Patients With Cryopyrin-Associated Periodic Syndromes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Inflazome UK Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Cryopyrin Associated Periodic Syndrome

Interventions

Type	Name	Description
DRUG	IZD334	Active Drug
DRUG	Placebos	Placebo to Match

Timeline

• Start date: 2019-09-13
• Primary completion: 2020-02-04
• Completion: 2020-02-04
• First posted: 2019-09-11
• Last updated: 2020-03-02

Locations

1 site across 1 country: Australia