Patients With Candidemia and/or Invasive CandidiasisPhase 2NCT06194201
A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
A Phase 2 study testing HRS9432 and Caspofungin Acetate for Injection in people with Patients With Candidemia and/or Invasive Candidiasis, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Candidemia and/or Invasive Candidiasis
- What is being tested?
- HRS9432 and Caspofungin Acetate for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2024to 7 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
- Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for >48 hours;
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- Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC;
- A history of drug use, alcohol, or drug abuse within 1 year prior to randomization;
- 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;
- Females who are in gestation or lactating period or planned pregnancy during the study
- Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs;
- In the judgment of the Investigator, other reasons unsuitable for study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, 421001
About this study
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
The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis
- Being tested
- HRS9432, Caspofungin Acetate for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9432Drug
Dosing frequency: intravenously once week
Caspofungin Acetate for InjectionDrug
Dosing frequency: D1 70mg，followed by 50mg intravenously once daily
| Study group | Role | What they receive |
|---|---|---|
| HRS9432 | Experimental | Not described Receives: Drug: HRS9432 |
| Caspofungin Acetate for Injection | Active comparator | Not described Receives: Drug: Caspofungin Acetate for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 14
Secondary outcomes (8)
Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) of HRS9432 IV in the mITT population
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day1 through End of Study (Day 56±3 days)
Percentage of Participants with mycological recurrence in the mITT population
Measured: 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
Measured: Day1 through End of Study (Day 56±3 days
Number of Participants With Adverse Events and severity
Measured: Day1 through End of Study (Day 56±3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start27 Apr 2024
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Candidemia and/or Invasive CandidiasisStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194201
- Sponsor's protocol ID
- HRS9432-201
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06194201
- Acronym / sponsor ID
- HRS9432-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS9432 | Experimental | Drug: HRS9432 |
| Caspofungin Acetate for Injection | Active comparator | Drug: Caspofungin Acetate for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS9432Dosing frequency: intravenously once week | Drug | HRS9432 |
| Caspofungin Acetate for InjectionDosing frequency: D1 70mg，followed by 50mg intravenously once daily | Drug | Caspofungin Acetate for Injection |
Primary outcome
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
8 secondary outcomes
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)]
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)
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)
Evaluate All cause Mortality in the mITT population
Time frame: 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
Time frame: Day1 through End of Study (Day 56±3 days)
Percentage of Participants with mycological recurrence in the mITT population
Time frame: 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
Time frame: Day1 through End of Study (Day 56±3 days
Number of Participants With Adverse Events and severity
Time frame: Day1 through End of Study (Day 56±3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS9432 and Caspofungin Acetate for Injection in people with Patients With Candidemia and/or Invasive Candidiasis, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.