Treatment of candidemia and invasive candidiasis with HRS9432

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

This study is testing a new drug called HRS9432 to see if it can effectively treat adults with serious yeast infections in their blood or body.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hengyang, Hunan)
• Trial ID: NCT06194201 on ClinicalTrials.gov

What this trial studies

This trial evaluates the efficacy and safety of intravenous HRS9432 in patients diagnosed with candidemia and/or invasive candidiasis. Participants will receive HRS9432 or Caspofungin Acetate for Injection to determine the effectiveness of the treatment. The study aims to enroll adults who exhibit systemic signs of these infections and are willing to provide informed consent. The trial is designed to assess both the therapeutic outcomes and safety profile of the drug.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of candidemia and/or invasive candidiasis.

Not a fit: Patients with specific forms of invasive candidiasis, severe hepatic impairment, or certain neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from serious fungal infections.

How similar studies have performed: While this approach is being tested in this specific context, similar antifungal treatments have shown promise in other studies.

Eligibility 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;
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.

Where this trial is running

Hengyang, Hunan

• The First Affiliated Hospital Of University Of South China — Hengyang, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Xiaopeng Wang

Conditions Patients With Candidemia and/or Invasive Candidiasis