Phase
Condition
Systemic Fungal Infections
Systemic Candidiasis
Sexually Transmitted Diseases (Stds)
Treatment
Caspofungin Acetate for Injection
HRS9432
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 priorto randomization;
Women of childbearing potential or male subjects whose partner is a fertile femaleagree 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
Exclusion Criteria:
Any of the following forms of IC: including osteomyelitis, endocarditis ormyocarditis, 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 sclerosisor a movement;
Laboratory abnormalities in baseline specimens obtained at screening;
ECG with clinical significance and may cause obvious safety risk to the subjects atscreening;
Received systemic treatment with an antifungal agent at approved doses for treatmentof candidemia or IC for >48 hours;
Vascular catheter or device that cannot be removed, or abscess that cannot bedrained, 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 activeinvestigational or experimental medication prior to the randomization, or 5half-lives, whichever is longer, prior to Screening;
Females who are in gestation or lactating period or planned pregnancy during thestudy
Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etcechinocandins drugs;
In the judgment of the Investigator, other reasons unsuitable for study.
Study Design
Connect with a study center
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan 421001
ChinaActive - Recruiting
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