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

NCT ID: NCT06194201

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-27
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HRS9432

Group Type: EXPERIMENTAL

HRS9432

Intervention Type: DRUG

Dosing frequency: intravenously once week

Caspofungin Acetate for Injection

Group Type: ACTIVE_COMPARATOR

Caspofungin Acetate for Injection

Intervention Type: DRUG

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

Interventions

HRS9432

Dosing frequency: intravenously once week

Intervention Type: DRUG

Caspofungin Acetate for Injection

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaopeng Wang

Role: CONTACT

xiaopeng.wang@hengrui.com

+86-182-6038-7118

Other Identifiers

HRS9432-201

Identifier Type: -

Identifier Source: org_study_id