drugset
drugset / Trial / NCT05121246

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

NCT05121246 ↗

Phase 1 Completed 150 enrolled mAbxience Research S.L.
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2022-06-15
Primary completion
2023-03-31
Completion
2023-03-31

Outcome

Missed primary endpoint

registry GEOMETRIC_LEAST_SQUARES_MEAN MB05 vs EU-Synagis®: 104.9 (86.9 to 126.6) ratio NCT05121246 ↗

registry GEOMETRIC_LEAST_SQUARES_MEAN MB05 vs US-Synagis®: 96.9 (79.7 to 117.8) ratio NCT05121246 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MB05 Unknown 3 mg/kg Intramuscular
Comparator Palivizumab Monoclonal antibody 3 mg/kg Intramuscular

Indications

No indication recorded.