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

Last updated: November 15, 2024
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Systemic Fungal Infections

Systemic Candidiasis

Sexually Transmitted Diseases (Stds)

Treatment

Caspofungin Acetate for Injection

HRS9432

Clinical Study ID

NCT06194201
HRS9432-201
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 priorto randomization;

  4. Women of childbearing potential or male subjects whose partner is a fertile femaleagree 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

Exclusion Criteria:

  1. Any of the following forms of IC: including osteomyelitis, endocarditis ormyocarditis, 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 sclerosisor 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 atscreening;

  6. Received systemic treatment with an antifungal agent at approved doses for treatmentof candidemia or IC for >48 hours;

  7. Vascular catheter or device that cannot be removed, or abscess that cannot bedrained, 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 activeinvestigational or experimental medication prior to the randomization, or 5half-lives, whichever is longer, prior to Screening;

  10. Females who are in gestation or lactating period or planned pregnancy during thestudy

  11. Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etcechinocandins drugs;

  12. In the judgment of the Investigator, other reasons unsuitable for study.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Caspofungin Acetate for Injection
Phase: 2
Study Start date:
April 27, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • The First Affiliated Hospital Of University Of South China

    Hengyang, Hunan 421001
    China

    Active - Recruiting

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