NCT05541107

Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Matinas BioPharma Nanotechnologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).

Detailed description

Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms or standard of care.

Conditions

• Cryptococcal Meningitis

Interventions

Type	Name	Description
DRUG	MAT2203	oral lipid nanocrystal amphotericin B
DRUG	Amphotericin B	Intravenous Amphotericin B

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-10-01
• Completion: 2025-01-01
• First posted: 2022-09-15
• Last updated: 2022-09-15

Regulatory

• FDA-regulated drug study