NCT05121246

A PK Study Comparing MB05, EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.

A Randomized, Double-Blind, 3-arm Parallel Study to Compare PK, Safety, IMM and Tolerability of MB05, EU-sourced Synagis® and US-sourced Synagis®, as a Single Dose Intramuscular Injection in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: mAbxience Research S.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

Detailed description

MB05 is being developed as a potential biosimilar to Synagis® for all indications for which Synagis® is approved. This study is designed to demonstrate PK similarity of the proposed biosimilar test product MB05 and the reference products EU- and US-Synagis®.This is a first-in-human study of the Synagis® biosimilar MB05. The reference product ynagis® was first approved by the US Food and Drug Administration (FDA) in 1998 and by the European Medicines agency (EMA) in 1999. As a proposed biosimilar, the clinical experience with Synagis® (as described in the Synagis® summary of product characteristics) (most recent versions) is deemed applicable to MB05.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MB05 (Proposed palivizumab biosimilar)	Single IM dose of 3 mg/kg
DRUG	EU-Synagis®	Single IM dose of 3 mg/kg
DRUG	US-Synagis®	Single IM dose of 3 mg/kg

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2021-11-16
• Last updated: 2025-04-02
• Results posted: 2025-04-02

Locations

3 sites across 2 countries: Australia, New Zealand