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Clinical Trial Summary

The primary objective of this study is to establish the safety and tolerability of multiple ascending doses (MAD) of foralumab enteric coated capsules administered orally, once daily for 5 days per week over 2 weeks in participants with moderate to severely active Crohn's Disease (CD).


Clinical Trial Description

Four different doses of foralumab enteric coated capsules will be studied for safety and tolerability in a MAD format. Participants in the sequential MAD cohorts will receive treatment when the safety data of one cohort are reviewed by the Data Safety Monitoring Board (DSMB) and are deemed favorable to proceed with the next treatment in the subsequent cohort. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05028946
Study type Interventional
Source Tiziana Life Sciences, PLC
Contact Venkat Renukuntla
Phone +1267-810-9994
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date October 28, 2021
Completion date November 7, 2023

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