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

NCT05534529 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-04-06

No results posted yet for this study

Summary

This study aimed to learn what levels of rezafungin were in the blood after dosing and how safe it was, in children and adolescents below 18 years old who were already receiving treatment for a fungal infection, a suspected fungal infection or at risk of fungal infection.

The main question the researchers wanted to answer in this trial was:

• What were the levels of rezafungin in the blood after the participants were dosed? The researchers also wanted to know what medical problems happened during this trial.

The participants in this trial received one dose of rezafungin on day 1 through a needle into a vein, called an intravenous (IV) infusion. The dose of rezafungin was measured in milligrams (mg) and given to the participants according to their body weight in kilograms (mg/kg).

The doctors checked the participants' health and asked questions about what medications they were taking and took blood samples to check the levels of rezafungin in the participants' blood.

After receiving the treatment at day 30, the doctors checked the participants' health.

This was an "open-label" trial. This means each participant knew what they were receiving, and the doctors and trial staff also knew.

Conditions

  • Invasive Fungal Infections

Interventions

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.

Sponsors & Collaborators

  • Mundipharma Research Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2024-05-23
Completion
2024-10-14

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05534529 on ClinicalTrials.gov