Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04015076
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2019-07-08
Brief Title:
Safety and Tolerability Pharmacokinetic and Pharmacodynamic Study With Inzomelid
Sponsor:
Inflazome UK Ltd
Organization:
Inflazome UK Ltd
Study Overview
Official Title:
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
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Sponsors Medical Monitor and an Independent Medical Monitor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None