NCT05707832

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

An Open Clinical Trial to Evaluate the Safety, Efficacy and Population Pharmacokinetics of Amphotericin B Cholesteryl Sulfate Complex for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study includes a screening period (day -14 to day -1), a baseline period (day 1), a treatment period, and a follow-up period (14±3 days after the end of administration). Eligible subjects will receive intravenous ABCD infusion. A test dose of 2 mg/10 mL will be given at baseline, followed by titration after the evaluation of the subjects' symptoms, signs and tolerance by investigator, until reaching the recommended dose of 3.0-4.0 mg/kg once a day for treatment. IC subjects will receive ABCD intravenous therapy for a minimum of 2 weeks, and a maximum of 14 days after the first negative turn of candida culture in blood or other normal sterile sites and the symptoms and signs of infection disappear/improve significantly, up to a maximum of 6 weeks. IA subjects will be treated with ABCD for at least 2 weeks and up to 6 weeks. After the end of intravenous therapy, according to the individual condition of the subjects, pathogens, drug sensitivity test, and the therapeutic effect of ABCD, the investigator will make a comprehensive judgment on whether to give sequential therapy drugs, but the total course of treatment shall not exceed the duration specified in the above scheme (the number of days of ABCD intravenous therapy plus the number of days of sequential therapy shall not exceed 6 weeks). The study will end when the last subject completed the follow-up period.

Conditions

• Invasive Candidiasis
• Invasive Aspergillosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-30
• Primary completion: 2024-07-30
• Completion: 2025-03-31
• First posted: 2023-02-01
• Last updated: 2025-04-09

Locations

1 site across 1 country: China