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

To date, there are no clinical studies evaluating rezafungin in paediatric subjects. The primary objective of the trial was to evaluate the pharmacokinetics (PK) of a single intravenous (IV) dose of rezafungin in paediatric participants from birth to \< 18 years, receiving concomitant systemic antifungals as prophylaxis for invasive fungal infection (IFI) or to treat a suspected or confirmed fungal infection. The secondary objective was to assess the safety and tolerability of a single IV dose of rezafungin in the subjects. This is a Phase 1, multicentre, open-label, single-dose study. The study will be conducted at approximately 10 sites across at least 3 countries in Europe. The study will be conducted in 3 parts: * Part 1 will include subjects aged 12 to \<18 years (Group 1) * Part 2 will include subjects aged 6 to \<12 years (Group 2), and subjects aged 2 to \<6 years (Group 3). * Part 3 will include subjects from birth to \<2 years (Group 4) The study design for the 3 parts is similar and comprises a Screening (pre-treatment) period from Day -3 to Day -1, Dosing on Day 1 (single IV infusion of rezafungin) followed by multiple PK sampling, and a Follow up visit on Day 30 (± 5 days). PK sampling will be performed at specified timepoints for each group. Limitations and Caveats Due to recruitment challenges, the study was terminated following enrollment of 2 participants aged between 12-17 years in Group 1 (Part 1). Group 2, 3 (Part 2) and Group 4 (Part 3) were not initiated prior to study termination. Due to the low number of participants in this study, baseline characteristics, outcome measure results and adverse events have not been reported to reduce the potential of re-identification.