Trial Profile

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

Status: Discontinued

Phase of Trial: Phase I

Latest Information Update: 11 Apr 2025

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At a glance

06 Apr 2025 Primary endpoints were updated to added 6 more pharmacokinetic end-points, namely AUC0-t, AUC0-infinity, CL, Vss, Vz, and t1/2.
06 Apr 2025 Status changed from suspended to discontinued, due to significant challenges in recruitment. The dosing of the first cohort was initially anticipated within 4-9 months of activation, but could not be achieved. Also, the study cannot be redesigned in order to adhere to the previously approved PIP plan.
18 Jun 2024 Status changed from recruiting to suspended.

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