The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Dosing frequency: intravenously once week
Dosing frequency: D1 70mg,followed by 50mg intravenously once daily
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China
RECRUITINGEvaluate 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
Time frame: Day 14
Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) of HRS9432 IV in the mITT population
Time frame: Day 5, Day 28, End of treatment(≤2 days of last dose) and End of Study (Day 56±3 days)]
Evaluate clinical cure as assessed by the Investigator for HRS9432 IV in the mITT population
Time frame: Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)
Evaluate mycological success(eradication) of HRS9432 IV in the mITT population
Time frame: Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)
Evaluate All cause Mortality in the mITT population
Time frame: Day 28 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
Time frame: Day1 through End of Study (Day 56±3 days)
Percentage of Participants with mycological recurrence in the mITT population
Time frame: 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
Time frame: Day1 through End of Study (Day 56±3 days
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Number of Participants With Adverse Events and severity
Time frame: Day1 through End of Study (Day 56±3 days)