Clinical trial NCT06194201: A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Official title: 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 and/or Invasive Candidiasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Patients With Candidemia and/or Invasive Candidiasis
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: 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
timeFrame: Day 14
Secondary outcomes:
measure: Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) of HRS9432 IV in the mITT population
timeFrame: Day 5, Day 28, End of treatment(≤2 days of last dose) and End of Study (Day 56±3 days)]
measure: Evaluate clinical cure as assessed by the Investigator for HRS9432 IV in the mITT population
timeFrame: Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)
measure: Evaluate mycological success(eradication) of HRS9432 IV in the mITT population
timeFrame: Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)
measure: Evaluate All cause Mortality in the mITT population
timeFrame: Day 28 and End of Study (Day 56±3 days)
measure: The time when two consecutive negative candida cultures occurred for the first time with an interval of ≥12h in the mITT population
timeFrame: Day1 through End of Study (Day 56±3 days)
measure: Percentage of Participants with mycological recurrence in the mITT population
timeFrame: End of Treatment (≤2 days of last dose) andEnd of Study (Day 56±3 days)
measure: Time of the first mycological recurrence in the mITT population
timeFrame: Day1 through End of Study (Day 56±3 days
measure: Number of Participants With Adverse Events and severity
timeFrame: Day1 through End of Study (Day 56±3 days)
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The First Affiliated Hospital Of University Of South China
state: Hunan
Study officials:
References: