NCT04015076

Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

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 Inzomelid in Healthy Adult Participants as Well as an Open Label Cohort to Confirm the Safety, Pharmacokinetics, and Pharmacodynamics of Inzomelid in Adult Patients With Cryopyrin-Associated Periodic Syndromes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Inflazome UK Ltd · Industry
• Sex: All
• Age: 18 Years – 70 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 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

Type	Name	Description
DRUG	Inzomelid	Active Drug
DRUG	Placebo	Placebo to Match

Timeline

• Start date: 2019-07-16
• Primary completion: 2020-03-23
• Completion: 2020-03-23
• First posted: 2019-07-10
• Last updated: 2020-03-27

Locations

1 site across 1 country: Australia