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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and/or invasive candidiasis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The First Affiliated Hospital Of University Of South China
RECRUITING
Hengyang
Contact Information
Primary
Xiaopeng Wang
xiaopeng.wang@hengrui.com
+86-182-6038-7118
Time Frame
Start Date: 2024-04-27
Estimated Completion Date: 2026-06
Participants
Target number of participants: 40
Treatments
Experimental: HRS9432
Active_comparator: Caspofungin Acetate for Injection
Related Therapeutic Areas
Sponsors
Leads: Fujian Shengdi Pharmaceutical Co., Ltd.