Safety, pharmacokinetics, and preliminary efficacy of VS-01, an intraperitoneal liposomal infusion, in patients with decompensated liver cirrhosis, ascites, and covert hepatic encephalopathy: a phase 1b, first-in-human, open-label, non-randomised, single ascending and multiple dose study

Key Points

• Overall safety of VS-01 was observed among patients with decompensated liver cirrhosis and ascites, indicating feasibility.
• The pharmacokinetics and preliminary efficacy of the liposomal infusion were promising in addressing hepatic encephalopathy.
• This open-label, non-randomised trial analyzed single ascending and multiple doses of VS-01 for potential therapeutic effects.
• Future studies should evaluate long-term outcomes to confirm efficacy and safety in diverse patient populations.

Abstract