Invasive Mold DiseasePhase 3NCT07239765
A Study to Evaluate the Safety, Efficacy, and PPK of ABCD in Patients With IMD
A Phase 3 study testing ABCD in people with Invasive Mold Disease, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Mold Disease
- What is being tested?
- ABCD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2021to 29 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou
About this study
Official title: 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.
- Conditions
- Invasive Mold Disease
- Being tested
- ABCD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABCDDrug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ABCD | Experimental | Patients received ABCD at a dose of 3-4 mg/kg for 2-12weeks Receives: Drug: ABCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Measured: Up to 14 weeks
Secondary outcomes (6)
The percentages of the patients who completed the 2 week ABCD therapeutic regimen
Measured: Up to 12 weeks
The percentages of the patients who completed the 4 week ABCD therapeutic regimen
Measured: Up to 12 weeks
The percentages of the patients who completed the 6 week ABCD therapeutic regimen
Measured: Up to 12 weeks
The proportion of patients achieving the clinical response of complete remission (CR), partial remission (PR) or stable disease (SD)
Measured: Up to 12 weeks
The proportion of patients achieving the clinical response of CR or PR
Measured: Up to 12 weeks
The proportion of patients with a microbiological response of eradication or presumed eradication
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start9 Jul 2021
- Primary completion8 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mold DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, Open-label, Single-arm Study
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239765
- Sponsor's protocol ID
- LXMSB201902/PRO-III
- Status last verified
- Sep 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07239765
- Acronym / sponsor ID
- LXMSB201902/PRO-III
- Conditions
- Invasive Mold Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, Open-label, Single-arm Study
| Arm | Type | Receives |
|---|---|---|
| ABCD | Experimental | Drug: ABCDPatients received ABCD at a dose of 3-4 mg/kg for 2-12weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABCDintravenous infusion | Drug | ABCD |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Up to 14 weeks
6 secondary outcomes
The percentages of the patients who completed the 2 week ABCD therapeutic regimen
Time frame: Up to 12 weeks
The percentages of the patients who completed the 4 week ABCD therapeutic regimen
Time frame: Up to 12 weeks
The percentages of the patients who completed the 6 week ABCD therapeutic regimen
Time frame: 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
The proportion of patients achieving the clinical response of CR or PR
Time frame: Up to 12 weeks
The proportion of patients with a microbiological response of eradication or presumed eradication
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABCD in people with Invasive Mold Disease, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.