NCT04031833

Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)

Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Matinas BioPharma Nanotechnologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cryptococcal Meningitis

Interventions

Type	Name	Description
DRUG	MAT2203	Encochleated amphotericin B
DRUG	Amphotericin B	Intravenous amphotericin B

Timeline

• Start date: 2019-10-24
• Primary completion: 2022-11-14
• Completion: 2023-02-15
• First posted: 2019-07-24
• Last updated: 2023-03-31

Locations

1 site across 1 country: Uganda

Regulatory

• FDA-regulated drug study