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

NCT ID NCT06194201

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

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

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

61 people

The number who actually took part.

Started

Apr 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Patients with candidemia and/or invasive candidiasis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The First Affiliated Hospital Of University Of South China

    Hengyang, Hunan, 421001, China