NCT05121246View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 15, 2022

Primary Completion Date

March 31, 2023

Study Completion Date

March 31, 2023

Conditions
Healthy Volunteers
Interventions
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

Trial Locations (3)

1010

New Zealand Clinical Research Ltd., Auckland

4006

Nucleus Network. Q-Pharm Pty Ltd, Brisbane

8011

New Zealand Clinical Research Ltd., Christchurch

All Listed Sponsors
lead

mAbxience Research S.L.

INDUSTRY