At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 150 enrolled
Drug / intervention
MB05 (Proposed palivizumab biosimilar) +2 moredrug
Likely dose
MB05 (Proposed palivizumab biosimilar) 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating MB05 (Proposed palivizumab biosimilar), EU-Synagis®, and 1 other intervention for Healthy Volunteers. Completed, enrolled 150 participants across 3 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesAustralia, New Zealand
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedNov 2021
Enrollment StartJun 2022
Primary CompletionMar 2023
TodayJul 2026
First PostedNov 16, 2021
Enrollment StartJun 15, 2022
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.6 years ago
Interventions
MB05 (Proposed palivizumab biosimilar)drug
Single IM dose of 3 mg/kg
EU-Synagis®drug
Single IM dose of 3 mg/kg
US-Synagis®drug
Single IM dose of 3 mg/kg