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A Phase Ib, dose escalation, placebo controlled study of oral formulation of Foralumab to healthy volunteers for the treatment of non-alcoholic steatohepatitis or fatty liver disease (NASH)

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Trial Profile

A Phase Ib, dose escalation, placebo controlled study of oral formulation of Foralumab to healthy volunteers for the treatment of non-alcoholic steatohepatitis or fatty liver disease (NASH)

Status: Suspended
Phase of Trial: Phase I

Latest Information Update: 08 May 2019

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At a glance

  • Drugs Foralumab (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Adverse reactions
  • Sponsors Tiziana Life Sciences

Most Recent Events

  • 01 May 2019 According to a Tiziana Life Sciences media release, Upon completion, the safety data from ongoing phase 1 trial with nasal administration will be provided to FDA as part of the revised IND for oral administration of enteric-coated capsules of foralumab in healthy volunteers. A further announcement will be made in due course following receipt of a response from FDA.
  • 01 May 2019 Status changed from planning to suspended, as reported in a Tiziana Life Sciences media release.
  • 01 May 2019 FDA also advised to cross-reference the submitted IND with nasal administration. Accordingly, the company has withdrawn the current IND to include safety data from the ongoing trial with nasal administration and adequately cross-reference the IND for nasal administration with solution of foralumab.

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