Status:
RECRUITING
A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Lead Sponsor:
Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions:
Patients With Candidemia and/or Invasive Candidiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06194201
Start Date
April 27 2024
End Date
June 1 2026
Last Update
November 18 2024
Active Locations (1)
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1
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China, 421001