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.

Study Overview

• Status: Completed
• Conditions: Invasive Mold Disease
• Intervention / Treatment: Drug: ABCD

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABCD; Patients received ABCD at a dose of 3-4 mg/kg for 2-12weeks	Drug: ABCD; intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (AEs)	Up to 14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The percentages of the patients who completed the 2 week ABCD therapeutic regimen	Up to 12 weeks
The percentages of the patients who completed the 4 week ABCD therapeutic regimen	Up to 12 weeks
The percentages of the patients who completed the 6 week ABCD therapeutic regimen	Up to 12 weeks
The proportion of patients achieving the clinical response of complete remission (CR), partial remission (PR) or stable disease (SD)	Up to 12 weeks
The proportion of patients achieving the clinical response of CR or PR	Up to 12 weeks
The proportion of patients with a microbiological response of eradication or presumed eradication	Up to 12 weeks

Collaborators and Investigators

• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): April 29, 2024

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: LXMSB201902/PRO-III

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No