NCT02629419

CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis

A Phase 2a Efficacy, Safety, Tolerability, and PK Study of Encochleated Amphotericin B (CAMB/MAT2203) in Patients With Mucocutaneous Candidiasis Who Are Refractory or Intolerant to Standard Non-Intravenous Therapies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Matinas BioPharma Nanotechnologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-titration trial to study the efficacy, safety, and pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous candidiasis infections in patients who are refractory or intolerant to standard non intravenous therapies.

Detailed description

Patients aged 18 to 75 years with mucocutaneous candidiasis (esophageal, oropharyngeal, or vulvovaginal) who are refractory or intolerant to standard non-intravenous therapies will be enrolled. Patients will initially be treated in a short-term dose titration period, where the dose may be increased in patients that do not respond clinically. Patients who do not respond clinically to the highest dose of drug will discontinue the protocol. Patients that respond to treatment and tolerate the study medication will be eligible to enter a long-term extension (up to 60-months).

Conditions

• Candidiasis, Chronic Mucocutaneous

Interventions

Type	Name	Description
DRUG	Amphotericin B	Oral lipid nanocrystal formulation of amphotericin B

Timeline

• Start date: 2016-09-27
• Primary completion: 2021-11-09
• Completion: 2022-08-06
• First posted: 2015-12-14
• Last updated: 2024-08-07
• Results posted: 2024-06-07

Locations

1 site across 1 country: United States