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Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334

NCT04086602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-03-02

No results posted yet for this study

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

DRUG

IZD334

Active Drug

DRUG

Placebos

Placebo to Match

Sponsors & Collaborators

  • Inflazome UK Ltd

    lead INDUSTRY

Principal Investigators

  • Jason Lickliter, MBBS, PhD · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086602 on ClinicalTrials.gov