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

HRS9432-201

The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis

2024-01-01

2026-06-01

2026-06-01

Not yet recruiting

Early phase I

40

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 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; or mild ataxia, tremor, neuropathic subjects receive moderate neurotoxic drugs; or plan or using severe neurotoxic drugs; 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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2024-01-08