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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Invasive Fungal Infections
• Intervention / Treatment: Drug: Rezafungin Acetate

Detailed 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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: S Lee; Phone Number: 82-2-527-9240; Email: seunghee.lee@mundipharma.co.kr

Study Locations

• Germany
  • Essen, Germany
    • Not yet recruiting
    • Universitätsklinikum Essen Zentrum für Kinder- und Jugendmedizin
  • Frankfurt, Germany
    • Not yet recruiting
    • Universitätsklinikum Frankfurt, Goethe Universität Klinik für Kinder- und Jugendmedizin
  • Münster, Germany
    • Recruiting
    • Universitätsklinikum Münster Klinik für Kinder- und Jugendmedizin
    • Contact: A Groll
• Spain
  • Burgos, Spain
    • Not yet recruiting
    • Hospital Universitario De Burgos
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario 12 de Octubre.
• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • Great Ormond Street Hospital For Children NHS Foundation Trust
  • London, United Kingdom
    • Not yet recruiting
    • Saint Mary's Hospital, Imperial College Healthcare NHS Trust
  • London, United Kingdom
    • Not yet recruiting
    • St. George's University Hospitals, NHS Foundation Trust
  • Southampton, United Kingdom
    • Not yet recruiting
    • Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female paediatric subjects from birth to <18 years of age who are receiving concomitant systemic antifungals (oral or IV) as prophylaxis for invasive fungal infection (IFI) or to treat a suspected or confirmed fungal infection.

Exclusion Criteria:

• History of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals and/or excipients of this formulation
• Previous or current medical conditions of severe ataxia, persistent tremors, intracranial hemorrhage or neuropathy, or a diagnosis of epilepsy, multiple sclerosis, or a movement disorder
• Subjects with impaired renal or hepatic functions
• Subjects with intestinal hypoxia, ischemia, necrosis, or necrotizing enterocolitis
• Subject status is unstable
• Subject is unlikely to complete required study procedures
• Participation in another interventional treatment trial with an investigational agent or presence of an investigational device at the time of informed consent or within 28 days preceding the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rezafungin; It is IMP.	Drug: Rezafungin Acetate; This is a Phase 1, multicentre, open-label, single-dose study. The study will be conducted at 10 sites across at least 3 countries in Europe.; Other Names: Rezafungin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK	Cmax	up to 30 days per patient
PK	Tmax	up to 30 days per patient

Collaborators and Investigators

• Sponsor: Mundipharma Research Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Anti-Infective Agents; Antifungal Agents; Rezafungin
• Other Study ID Numbers: MR907-1501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No