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A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus

NCT05707832 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-04-09

No results posted yet for this study

Summary

This is a multi-center, open-label, non-controlled, single-arm clinical trial to evaluate the safety, efficacy and population pharmacokinetics of Amphotericin B cholesteryl Sulfate Complex for Injection domestic formulations (ABCD) in the treatment of confirmed invasive candidiasis (IC) and confirmed/clinically diagnosed invasive aspergillus (IA) disease.

Conditions

  • Invasive Candidiasis
  • Invasive Aspergillosis

Interventions

DRUG

Amphotericin B cholesteryl Sulfate Complex for Injection

Intravenous injection (IV), once a day after reaching the recommended dose of 3.0-4.0 mg/kg for treatment. Subjects will receive ABCD intravenous therapy for at least 2 weeks, and the longest course of treatment will not exceed 6 weeks.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sizhou Feng · Chinese Academy of Medical Sciences

  • Mei Hong · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • Ming H · Qilu Hospital of Shandong University

  • Suning Chen · The First Affiliated Hospital of Soochow University

  • Jinhai Ren · The Second Hospital of Hebei Medical University

  • Jishi Wang · The Affiliated Hospital Of Guizhou Medical University

  • Fenge Yang · Union Hospital Affiliated to Fujian Medical University

  • Fang Zhou · Chinese the 960th Hospital of the Joint Logistics Support Department of the People's Liberation Army

  • Ming Jiang · First Affiliated Hospital of Xinjiang Medical University

  • Baodong Ye · The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

  • Lina Zhang · Henan Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2024-07-30
Completion
2025-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05707832 on ClinicalTrials.gov