Health TrialsbyHealthPanel

A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

ConditionPatients 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS9432

    Drug

    Dosing frequency: intravenously once week

  • Caspofungin Acetate for Injection

    Drug

    Dosing frequency: D1 70mg，followed by 50mg intravenously once daily

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: HRS9432Experimental treatment 1 intervention
Group B: Caspofungin Acetate for InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 14

Secondary outcomes

1

Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) of HRS9432 IV in the mITT population

Time frame
Day 5, Day 28, End of treatment(≤2 days of last dose) and End of Study (Day 56±3 days)]
2

Evaluate clinical cure as assessed by the Investigator for HRS9432 IV in the mITT population

Time frame
Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)
3

Evaluate mycological success(eradication) of HRS9432 IV in the mITT population

Time frame
Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)
4

Evaluate All cause Mortality in the mITT population

Time frame
Day 28 and End of Study (Day 56±3 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now