Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2026-01-08 @ 2:29 PM
Study NCT ID:
NCT04031833
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)
Sponsor:
Matinas BioPharma Nanotechnologies, Inc.
Organization:
Study Overview
Official Title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial
Status:
COMPLETED
Status Verified Date:
2023-03
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:
EnACT
Brief Summary:
This study is designed as two sequential trials. The first is a phase I open label trial to evaluate the safety and tolerability of MAT2203. The maximal tolerated and non-toxic daily dose,will then be moved forward into a multi-day safety trial. The Phase II trial will investigate toxicity and early fungicidal activity (EFA) of MAT2203 with flucytosine.
Detailed Description:
Cryptococcal meningitis has emerged as one of the most frequent and deadly opportunistic infections in HIV patients. Historically, amphotericin B (AMB) has been considered the "gold standard" in antifungal treatments due to its broad spectrum of activity and lack of emergence of resistance. However, the use of AMB is limited by side effects, including nephrotoxicity, anemia, and infusion-related reactions. MAT2203 or encochleated oral amphotericin B (cAMB) is a lipid nano-crystal formulation designed for targeted oral delivery of the antifungal drug AMB for treatment of fungal and parasitic infections.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: