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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501985-23-00

Acronym

MR907-1501

Enrollment

Registered

2023-04-18

Start date

2023-05-18

Completion date

2024-10-14

Last updated

2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal infections

Brief summary

Parts 1 and 2: The following PK parameters will be assessed: Cmax, Tmax, AUC0-t, AUC0-∞, CL, Vss, Vz, t1/2, Part 3: Rezafungin plasma concentrations

Detailed description

The safety evaluation will be based on clinical review of the following parameters: • Incidence of treatment-emergent adverse events (TEAEs) • Clinical laboratory evaluations (including haematology, blood chemistry and urinalysis) • Vital signs • 12-lead electrocardiograms (ECGs): clinically significant abnormalities • Physical examination findings

Interventions

DRUGREZZAYO 200 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Parts 1 and 2: The following PK parameters will be assessed: Cmax, Tmax, AUC0-t, AUC0-∞, CL, Vss, Vz, t1/2, Part 3: Rezafungin plasma concentrations	—

Secondary

Measure	Time frame
The safety evaluation will be based on clinical review of the following parameters: • Incidence of treatment-emergent adverse events (TEAEs) • Clinical laboratory evaluations (including haematology, blood chemistry and urinalysis) • Vital signs • 12-lead electrocardiograms (ECGs): clinically significant abnormalities • Physical examination findings	—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026