RecruitingPhase 2

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

China40 participantsStarted 2024-04-27

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or invasive candidiasis [IC]) of HRS9432 IV in subjects with candidemia and/or IC in the Microbiological Intent-to-treat (mITT) population

Timeframe: Day 14

Trial details

NCT IDNCT06194201

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Xiaopeng Wang

+86-182-6038-7118 xiaopeng.wang@hengrui.com

View on ClinicalTrials.gov More Patients With Candidemia and/or Invasive Candidiasis trials