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

NCT06194201 | Completed Phase 2

• 1 other identifier: HRS9432-201
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

Patients With Candidemia and/or Invasive Candidiasis

Outcome Measures

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

  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

  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

  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

  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

  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

  Day1 through End of Study (Day 56±3 days)

Study Arms (2)

HRS9432

EXPERIMENTAL

Drug: HRS9432

Caspofungin Acetate for Injection

ACTIVE COMPARATOR

Drug: Caspofungin Acetate for Injection

Interventions

HRS9432 DRUG

Dosing frequency: intravenously once week

HRS9432

Caspofungin Acetate for Injection DRUG

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

Caspofungin Acetate for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, 421001, China

Location

MeSH Terms

Interventions

Caspofungin; Injections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 8, 2024
• Study Start: April 27, 2024
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

CN (1)