This is a Phase 2a, randomized, double-blind, placebo-controlled, dose- escalation, proof-of-concept study to evaluate the safety, tolerability, early efficacy, and PK of INT-787 in subjects, initially admitted to the hospital, with severe alcohol-associated hepatitis (sAH). The study aims to demonstrate and provide rationale for the selection of optimal dose(s) of INT-787 in the target population of subjects with sAH. INT-787 will be evaluated for safety and tolerability prior to dose escalation. Overall early efficacy, based on the Lille score at Day 7 compared to placebo, will be assessed for each dose cohort.~Additionally, pharmacokinetic measurements at various study timepoints will allow the Sponsor to better understand the systemic exposure of INT-787 and the relationship between exposure and efficacy and safety. Such insights in subjects with more advanced liver disease will provide valuable information for future clinical trials of INT-787.~The placebo-treated subjects will provide important natural history information on outcomes in this patient population with sAH treated with supportive care. The placebo-treated subjects within cohorts are meant to blind the study drug administration while the data across dose cohorts will be used in the overall analysis.
The purpose of this trial is to assess dose related safety, early efficacy, pharmacokinetics and pharmacodynamics of INT-787 in patients with severe alcohol-associated hepatitis (sAH).