Rezafungin Paediatric PK Study
Research type
Research Study
Full title
A Phase 1, Multicentre, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single IV Dose of Rezafungin Acetate in Paediatric Subjects from Birth to <18 Years of Age, Receiving Systemic Antifungals as Prophylaxis for Invasive Fungal Infection or to Treat a Suspected or Confirmed Fungal Infection
IRAS ID
1006739
Contact name
Gu-Lung Lin
Contact email
Sponsor organisation
Mundipharma Research Ltd.
Eudract number
0000-000000-00
Clinicaltrials.gov Identifier
Research summary
Mundipharma Research Ltd. is running a study to evaluate the amount of rezafungin in the bloodstream and the safety and tolerability of a single dose of rezafungin in infants, children, and adolescents. Rezafungin belongs to the echinocandin class of antifungal drugs and is in clinical development. Studies show that rezafungin is comparable to caspofungin, an echinocandin that’s been used to treat invasive Candida infections in children and adults for >20 years.
This will be the first clinical study of rezafungin conducted in the paediatric population, from birth to <18 years of age. The primary aim is to understand how rezafungin is distributed in and removed from the body of paediatric participants. The secondary aim is to see if a single dose of rezafungin is safe and tolerated, via regular measurements of heart/respiratory rate, temperature, blood pressure, physical examinations, blood and urine tests, and electrocardiograms (ECGs).
The study will run in Europe and enrol 32–40 paediatric patients who are receiving an antifungal drug to treat a fungal infection or prevent invasive fungal infections. Eligible patients will be enrolled into 1 of the 4 groups: Group 1 (12 to <18 years), Group 2 (6 to <12 years), Group 3 (2 to <6 years), and Group 4 (birth to <2 years). Enrolment of Group 1 will start first (Part 1), followed by a review of the drug concentration and safety data. Parallel enrolment of Groups 2 and 3 (Part 2) will only start once drug concentrations are confirmed to be acceptable and rezafungin is safe and well tolerated. Another review for drug concentrations and safety will be performed when 50% of participants in Part 2 have completed the study, and a third review will be performed prior to enrolment of Group 4 (Part 3).
The maximum duration of participation is 33 days, consisting of a 3-day screening period, a single dose of rezafungin, and a 30-day follow-up period.
Mundipharma Research Ltd. is the sponsor and will organise/fund this study.REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0862
Date of REC Opinion
10 May 2023
REC opinion
Further Information Favourable Opinion