A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Shengdi Pharmaceutical Co., Ltd.
About this trial
The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis
Eligibility criteria
Qualifiers
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；
Disqualifiers
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;
Trial design
Treatments tested in this trial
- HRS9432
- Caspofungin Acetate for Injection
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov