A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

Recruitment & Eligibility

Inclusion Criteria

Males or females ≥18 years；
Established or clinical diagnosis of candidemia and/or IC ；
Present of 1 or more systemic signs attribute to candidemia and/or IC 4 days prior to randomization;
Women of childbearing potential or male subjects whose partner is a fertile female agree to use highly effective form of contraception from the time of signed ICF till 6 months after end of treatment；
Able and willing to provide a written informed consent

Exclusion Criteria

Any of the following forms of IC: including osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, or any central nervous system infection, urinary tract infection or chronic disseminated candidiasis；
Severe hepatic impairment in subjects with a history of chronic cirrhosis；
History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement;
Laboratory abnormalities in baseline specimens obtained at screening;
ECG with clinical significance and may cause obvious safety risk to the subjects at screening;
Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for >48 hours;
Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC;
A history of drug use, alcohol, or drug abuse within 1 year prior to randomization;
Participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to Screening;
Females who are in gestation or lactating period or planned pregnancy during the study
Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs;
In the judgment of the Investigator, other reasons unsuitable for study.

Study & Design

Arm && Interventions

Group	Intervention	Description
HRS9432	HRS9432	-
Caspofungin Acetate for Injection	Caspofungin Acetate for Injection	-

Primary Outcome Measures

Name	Time	Method
Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or invasive candidiasis [IC]) of HRS9432 IV in subjects with candidemia and/or IC in the Microbiological Intent-to-treat (mITT) population	Day 14

Secondary Outcome Measures

Name	Time	Method
Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) of HRS9432 IV in the mITT population	Day 5, Day 28, End of treatment(≤2 days of last dose) and End of Study (Day 56±3 days)]
Number of Participants With Adverse Events and severity	Day1 through End of Study (Day 56±3 days)
Evaluate clinical cure as assessed by the Investigator for HRS9432 IV in the mITT population	Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)
The time when two consecutive negative candida cultures occurred for the first time with an interval of ≥12h in the mITT population	Day1 through End of Study (Day 56±3 days)
Evaluate All cause Mortality in the mITT population	Day 28 and End of Study (Day 56±3 days)
Evaluate mycological success(eradication) of HRS9432 IV in the mITT population	Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)
Percentage of Participants with mycological recurrence in the mITT population	End of Treatment (≤2 days of last dose) andEnd of Study (Day 56±3 days)
Time of the first mycological recurrence in the mITT population	Day1 through End of Study (Day 56±3 days

Recruitment & Eligibility