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Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

NCT04015076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-03-27

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 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.

Conditions

  • Healthy

Interventions

DRUG

Inzomelid

Active Drug

DRUG

Placebo

Placebo to Match

Sponsors & Collaborators

  • Inflazome UK Ltd

    lead INDUSTRY

Principal Investigators

  • Ben Snyder, MB, BS · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2020-03-23
Completion
2020-03-23

Countries

  • Australia

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Entities

Drugs

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 NCT04015076 on ClinicalTrials.gov