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

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
• Treatments: Caspofungin

Criteria

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.