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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07239765

Enrollment

Registered

2025-11-20

Start date

2021-07-09

Completion date

2024-04-29

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Mold Disease

Brief summary

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.

Interventions

DRUGABCD

intravenous infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multicenter, Open-label, Single-arm Study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
The percentages of the patients who completed the 6 week ABCD therapeutic regimen	Up to 12 weeks
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 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
The proportion of patients achieving the clinical response of complete remission (CR), partial remission (PR) or stable disease (SD)	Up to 12 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026