A Study to Evaluate the Safety, Efficacy, and PPK of ABCD in Patients With IMD

An Open-label Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetic Characteristics of Amphotericin B Cholesteryl Sulfate Complex Injection in Patients With Invasive Mold Disease

Amphotericin B Cholesteryl Sulfate Complex (ABCD) is a generic drug of amphotericin B colloidal dispersion. This study aimed to explore the safety and efficacy of ABCD in patients with invasive mold disease.

Inclusion Criteria:

• ≥18 years of age;
• Participant had a diagnosis of proven/probable invasive mold disease (IMD) as determined according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC-MSG) criteria (2019 version) or proven/probable talaromycosis as determined according to diagnostic criteria for endemic mycosis.

Exclusion Criteria:

• Allergy to amphotericin B or cholesteryl sulfate complex;
• Mycoses only involved skin above fascia;
• Expected survival less than 2 months;
• Pregnant or breast-feeding;
• Non-negative result on HIV antibody