RecruitingPhase 2

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

China40 participantsStarted 2024-04-27

Plain-language summary

The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT06194201

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Xiaopeng Wang

+86-182-6038-7118 xiaopeng.wang@hengrui.com

View on ClinicalTrials.gov More Patients With Candidemia and/or Invasive Candidiasis trials