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The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS9432 | Experimental |
| |
| Caspofungin Acetate for Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9432 | Drug | Dosing frequency: intravenously once week |
| |
| Caspofungin Acetate for Injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] | |
| Evaluate clinical cure as assessed by the Investigator for HRS9432 IV in the mITT population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaopeng Wang | Contact | +86-182-6038-7118 | xiaopeng.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Of University Of South China | Recruiting | Hengyang | Hunan | 421001 | China |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Drug |
Dosing frequency: D1 70mg,followed by 50mg intravenously once daily |
|
| 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 | 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 | 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 | Day1 through 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 |
| Number of Participants With Adverse Events and severity | Day1 through End of Study (Day 56±3 days) |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |