A multi-centre, randomized, double-blind, active controlled, parallel groups, phase II study to evaluate the efficacy and safety of intravenous HRS9432 in the treatment of subjects with candidemia and/or invasive candidiasis
NCT ID NCT06194201
First seen Sep 10, 2026 · Last updated Sep 10, 2026
Summary
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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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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61 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or females ≥18 years; 2. Established or clinical diagnosis of candidemia and/or IC ; 3. Present of 1 or more systemic signs attribute to candidemia and/or IC 4 days prior to randomization; 4. 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; 5. Able and willing to provide a written informed consent Exclusion Criteria: 1. 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; 2. Severe hepatic impairment in subjects with a history of chronic cirrhosis; 3. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement; 4. Laboratory abnormalities in baseline specimens obtained at screening; 5. ECG with clinical significance and may cause obvious safety risk to the subjects at screening; 6. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for \>48 hours; 7. Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC; 8. A history of drug use, alcohol, or drug abuse within 1 year prior to randomization; 9. 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; 10. Females who are in gestation or lactating period or planned pregnancy during the study 11. Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs; 12. In the judgment of the Investigator, other reasons unsuitable for study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, 421001, China