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PB006 versus EU and US Tysabri pharmacokinetic/pharmacodynamic comparability study in healthy adults
NL-OMON49168Completed
- Sponsor
- Polpharma Biologics
- Start
- Oct 2019
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Countries
- 1
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Overview
Randomised, double-blind trial of PB006 and natalizumab in multiple sclerosis (MS) and Crohn's disease (3 arms), sponsored by Polpharma Biologics. Primary endpoints: AUC0-inf of total natalizumab: PB006 versus US-licensed Tysabri, AUC0-inf of total natalizumab: PB006 versus EU-approved Tysabri and 3 more. Started Oct 2019; status: completed.
02
Drugs
PB006natalizumab
03
Conditions
multiple sclerosis (MS)Crohn's disease
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