Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Inzomelid; Drug: Placebo

• Registration Number: NCT04015076
• Lead Sponsor: Inflazome UK Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-10
• Study Start: 2019-07-16
• Status Verified: 2020-02
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-23
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose	Inzomelid	Inzomelid or Placebo
Single Ascending Dose	Placebo	Inzomelid or Placebo
Multiple Ascending Dose	Placebo	Inzomelid or Placebo
Multiple Ascending Dose	Inzomelid	Inzomelid or Placebo
Patients with CAPS	Inzomelid	Inzomelid Open Label

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent advert events [Safety and Tolerability]	Day 1-8 for SAD, Day 1-16 for MAD	Incidence, frequency and severity of treatment emergent advert events
Area under the plasma concentration versus time curve (AUC)- single dose	Day 1-3	AUC following single dose administration
Peak Plasma Concentration (Cmax)-single dose	Day 1-3	Peak plasma concentration following single dose administration
Peak Plasma Concentration (Cmax)-multiple dose	Days 1-16	Peak plasma concentration following multiple dose administration
Area under the plasma concentration versus time curve (AUC)- multiple dose	Days 1-16	AUC following multiple dose administration

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic activity	Day 1-3 for SAD and Day 1-9 for MAD	NLRP3 Inhibition in whole blood
Reduction in CAPS symptom scores	Days 1-15	Reduction in Physician Assessed CAPS scores based on 8 point questionnaire

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Melbourne, Queensland, Australia