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

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Patients With Candidemia and/or Invasive Candidiasis

Treatments: Drug: HRS9432; Drug: Caspofungin Acetate for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06194201

HRS9432-201

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

HRS9432

Experimental group

Treatment:

Drug: HRS9432

Caspofungin Acetate for Injection

Active Comparator group

Treatment:

Drug: Caspofungin Acetate for Injection