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

November 16, 2025 updated by: CSPC Ouyi Pharmaceutical Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Up to 14 weeks
Up to 14 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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