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)
Phase of Trial: Phase I
Latest Information Update: 01 May 2019
Price : $35 *
At a glance
- Drugs Foralumab (Primary)
- Indications Non-alcoholic steatohepatitis
- Focus Adverse reactions
- Sponsors Tiziana Life Sciences
- 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 Accordingly, the company has withdrawn the current IND to include safety data from the ongoing trial with nasal administration and adequately cross-reference the IND for nasal administration with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.