RecruitingPhase 2NCT06194201

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

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


Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Enrollment

40 participants

Start Date

Apr 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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.

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Interventions

DRUGHRS9432

Dosing frequency: intravenously once week

DRUGCaspofungin Acetate for Injection

Dosing frequency: D1 70mg,followed by 50mg intravenously once daily


Locations(1)

The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, China

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NCT06194201