Patients With Candidemia and/or Invasive Candidiasis
Conditions
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
Interventions
DRUGHRS9432
Dosing frequency: intravenously once week
DRUGCaspofungin Acetate for Injection
Dosing frequency: D1 70mg，followed by 50mg intravenously once daily
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females ≥18 years； 2. Established or clinical diagnosis of candidemia and/or IC ； 3. Present of 1 or more systemic signs attribute to candidemia and/or IC 4 days prior to randomization; 4. 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； 5. Able and willing to provide a written informed consent
Exclusion criteria
1. 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； 2. Severe hepatic impairment in subjects with a history of chronic cirrhosis； 3. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement; 4. Laboratory abnormalities in baseline specimens obtained at screening; 5. ECG with clinical significance and may cause obvious safety risk to the subjects at screening; 6. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for \>48 hours; 7. Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC; 8. A history of drug use, alcohol, or drug abuse within 1 year prior to randomization; 9. 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; 10. Females who are in gestation or lactating period or planned pregnancy during the study 11. Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs; 12. In the judgment of the Investigator, other reasons unsuitable for study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) of HRS9432 IV in the mITT population | Day 5, Day 28, End of treatment(≤2 days of last dose) and End of Study (Day 56±3 days)] |
| Evaluate clinical cure as assessed by the Investigator for HRS9432 IV in the mITT population | Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days) |
| Evaluate mycological success(eradication) of HRS9432 IV in the mITT population | Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days) |
| Evaluate All cause Mortality in the mITT population | Day 28 and End of Study (Day 56±3 days) |
| The time when two consecutive negative candida cultures occurred for the first time with an interval of ≥12h in the mITT population | Day1 through End of Study (Day 56±3 days) |
| Percentage of Participants with mycological recurrence in the mITT population | End of Treatment (≤2 days of last dose) andEnd of Study (Day 56±3 days) |
| Time of the first mycological recurrence in the mITT population | Day1 through End of Study (Day 56±3 days |
| Number of Participants With Adverse Events and severity | Day1 through End of Study (Day 56±3 days) |
Countries
China
Outcome results
None listed