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Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age

Invasive Fungal Infections Clinical Trial

Official title:
A Phase 1, Multicentre, Open-Label Study to Evaluate the PK, Safety, and Tolerability of a Single IV Dose of Rezafungin in Paediatric Subjects, Receiving Systemic Antifungals as Prophylaxis for IFI or to Treat a Suspected or Confirmed FI

Clinical Trial Summary

This study will assess the pharmacokinetics (PK), safety, and tolerability of a single intravenous (IV) dose of rezafungin in paediatric subjects from birth to <18 years who are receiving concomitant systemic antifungals as clinically indicated.

Clinical Trial Description

To date, there are no clinical studies evaluating rezafungin in paediatric subjects. This study will assess the pharmacokinetics (PK), safety and tolerability of rezafungin in subjects from birth to <18 years of age who are receiving concomitant systemic antifungal treatment as standard of care. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05534529
Study type Interventional
Source Mundipharma Research Limited
Contact S Lee
Phone 82-2-527-9240
Email seunghee.lee@mundipharma.co.kr
Status Recruiting
Phase Phase 1
Start date September 13, 2023
Completion date December 2027
View Details
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