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

Sponsor
Mundipharma Research Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05534529
Collaborator
(none)
32
Enrollment
1
Arm
58
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rezafungin Acetate
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PK [up to 30 days per patient]

      Cmax

    2. PK [up to 30 days per patient]

      Tmax

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mundipharma Research Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mundipharma Research Limited
    ClinicalTrials.gov Identifier:
    NCT05534529
    Other Study ID Numbers:
    • MR907-1501
    First Posted:
    Sep 9, 2022
    Last Update Posted:
    Sep 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycoses
    Invasive Fungal Infections
    Rezafungin

    Study Results

    No Results Posted as of Sep 9, 2022