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PK, Safety, and Immunogenicity of SB17 (Ustekinumab Biosimilar) vs Stelara in Healthy Subjects
NCT04772274Phase 1Completed
- Sponsor
- Samsung Bioepis
- Start
- Feb 2021
- Primary completion
- Apr 2022
- Modality
- Monoclonal Antibodies
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of ustekinumab-ttwe in plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease and 1 more (3 arms), sponsored by Samsung Bioepis. Primary endpoints: Area Under the Concentration-time Curve from Time Zero to Infinity and Maximum Observed Serum Concentration. Started Feb 2021; status: completed.
02
Drugs
ustekinumab-ttwe
03
Conditions
plaque psoriasispsoriatic arthritis (PsA)Crohn's diseaseulcerative colitis (UC)
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