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

Inclusion Criteria:

1. Age ≥18 years old, male or female;

2. Subjects who meet the EORTC-MSG diagnostic criteria and are diagnosed with invasivecandidiasis (confirmed) or invasive aspergillus disease (confirmed or clinical)according to the Revised Definition of Invasive Mycosis: IC confirmed subjects arepositive candida culture reports from blood or other sterile samples obtained within 48 hours prior to enrollment; Or the histopathological/cytopathological examinationreport of needle aspiration or biopsy specimens from normal sterile except mucosawithin 2 weeks showed the presence of candida; IA confirmed subjects are defined asdiseased tissue (sterile sampling) obtained within 4 weeks prior to enrollment withdefinite fungal presence (cytology, microscopy, or culture, etc.). The clinicaldiagnosis of IA includes at least one host factor, one clinical criterion, and onemicrobiological criterion (serum, sputum, bronchoalveolar lavage fluid, bronchialbrush specimen, or sinus extract indicating positive Aspergillus GM test);

3. All subjects agreed to use contraception from the time signed the informed consentto 6 weeks after the end of the last dose;

4. Female subjects must meet one of the following conditions: have surgicalsterilization; postmenopausal, menopause at least 1 year; or for those withfertility, must satisfy the following conditions: negative human chorionicgonadotropin (HCG) serum test results prior to enrollment; avoidance of sexualbehavior throughout the study period, or agreement to use a recognized and highlyeffective contraceptive measure [defined as being able to be used consistently andcorrectly with a failure rate of less than 1% per year, such as: condoms, combinedhormones (including estrogen and progesterone) combining inhibit ovulation,progestin contraception combined with ovulation suppression, intrauterine device (IUD), intrauterine hormone release system (IUS), bilateral tubal ligation,bilateral vasectomy], and the contraceptive methods remained unchanged throughoutthe study period;

5. Male subjects must have been surgically sterilized or their female partners musthave met any of #4 above, and their contraceptive methods remained unchanged duringthe study period;

6. Subjects and/or guardian fully understand, voluntarily participate in this study andsign the informed consent form.

Exclusion Criteria:

1. Allergic to amphotericin B drugs or cholesterol sulfate complex antifungal drugs;

2. IC subjects received systemic antifungal therapy for ≥3 days within 1 week prior toenrollment (subjects with no improvement in symptoms of infection after treatment orwith positive blood culture candida can still be enrolled; Subjects with neutropeniacan use triazole prophylaxis for an unlimited days);

3. IA subjects received systemic antifungal therapy for more than 96 hours within 1week prior to enrollment (subjects with no improvement in symptoms of infectionafter treatment or those with positive microbiological criteria can still beenrolled), or prophylactic therapy for more than 13 days or common amphotericin Bwith cumulative dose of more than 10 mg/kg within 10 days prior to enrollment, oruse amphotericin lipids with a cumulative dose of more than 15 mg/kg;

4. Evidence of infection in subjects is limited to positive candida cultures in urine (other than those diagnosed with pyelonephritis), sputum and bronchoalveolar lavagefluid, catheter tops, drainage fluid, or other mucous membranes or superficial skinsurfaces (e.g. vagina or other external genitalia, colon, oropharynx, esophagus,skin folds, nail beds, etc.);

5. Subjects with suspected candida endocarditis, osteomyelitis, arthritis,endophthalmitis, liver and spleen abscess, suppurative thrombophlebitis, or centralnervous system infection;

6. Candida culture positive samples collected 24 hours after the non first placement ofthe catheter or drainage tube at the sterile site;

7. Intravenous catheterization is associated with aggressive candidiasis in subjectswhose catheters could not be removed or replaced during the study period;

8. Subjects with chronic pulmonary aspergillus disease (duration ≥3 months),aspergilloma or allergic bronchopulmonary aspergillus disease;

9. Subjects are known to have mixed invasive Candida or Aspergillus infections and/orare not sensitive to or resistant to amphotericin B treatment, such as subjects withinvasive Aspergillus terreus and Aspergillus nidulans;

10. Subjects who have been fitted with an artificial device (other than intravenouscatheterization) and are suspected of being the source of infection and cannot havethe device removed within 24 hours after enrollment;

11. Subjects with abnormal liver function (aspartate aminotransferase (AST) or alanineaminotransferase (ALT) ≥5 times the upper limit of normal without increase in totalbilirubin, or ALT or AST increase 3 times the upper limit of normal with 1.5 timesincrease in total bilirubin);

12. Subjects with renal dysfunction who require or are currently undergoing hemodialysisor peritoneal dialysis;

13. Subjects with clinically significant hypokalemia (defined as serum potassiumconcentration <3.2 mmol/L, or below the lower limit of normal in subjects undergoingdigitalization ) and whose hypokalemia could not be corrected before beginningtreatment;

14. Subjects who plan to use prohibited drugs during the study;

15. The expected survival time is less than 2 months;

16. Unstable medical conditions other than diseases of the hematopoietic system, such asdisorders or impairment of the heart or nervous system, that are expected to beunstable or progressive over the course of the study (e.g. epilepsy or demyelinatingsyndrome, acute myocardial infarction, myocardial ischemia or unstable congestiveheart failure, unstable arrhythmia, atrial fibrillation with ventricular rate <60/min, or a history of tip torsion, symptomatic ventricular or persistent arrhythmiaswithin 3 months prior to enrollment)

17. Degree Ⅱ type 2 or Ⅲ atrioventricular block and long QT syndrome or QTc>470 ms (female) /450 ms (male) on the 12-lead ECG without pacemaker installation;

18. Subjects with NYHA grade Ⅲ/Ⅳ cardiac function;

19. HIV antibody positive at first screening;

20. Pregnant and lactating women;

21. A history of drug abuse (non-medical use of narcotic drugs or psychotropic drugs)and a history of drug dependence (sedatives, hypnotics, analgesics, narcotics,stimulants, antipsychotics, etc.);

22. Subjects who have participated in clinical trials of other drugs or medical deviceswithin three months prior to screening (except those who are signed to be informedbut not enrolled for drug administration or medical device treatment);

23. Subjects who have participated in this study (except for prior effective use of thisproduct and after 5 half-lives of this product or 14 days of washout prior toscreening);

24. Not suitable for this study as decided by the investigator due to complicated withsevere organ insufficiency, clinically significant laboratory abnormalities,comprehension or compliance problems, etc.