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 andor Invasive Candidiasis

Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2024-11-18

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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

CONDITIONS

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

Age: 18Years +

All Genders

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;
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;
Females who are in gestation or lactating period or planned pregnancy during the study
Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs;
In the judgment of the Investigator, other reasons unsuitable for study.

Xiaopeng Wang

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