Safety, Pharmacokinetics, & Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-associated Hepatitis

• Published in: The American journal of gastroenterology Vol. 119; no. 1; pp. 107 - 115
• Main Authors: Hassanein, Tarek, McClain, Craig J., Vatsalya, Vatsalya, Stein, Lance L., Flamm, Steven L, Martin, Paul, Cave, Matthew C., Mitchell, Mack, Barton, Bruce, Nagy, Laura, Szabo, Gyongyi, McCullough, Arthur, Dasarathy, Srinivasin, Shah, Jaymin, Blevins, Christina, Scott, Deborah, Krebs, William, Brown, James E., Lin, WeiQi
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer 01.01.2024; Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
• Subjects: Alcohol; Clinical trials; Consent; DNA methylation; Drug dosages; End Stage Liver Disease; Enrollments; Epigenetics; FDA approval; Hepatitis; Hepatitis, Alcoholic - diagnosis; Hepatitis, Alcoholic - drug therapy; Hospitalization; Hospitals; Human subjects; Humans; Infections; Liver; Liver diseases; Mortality; Pharmacokinetics; Pilot Projects; Severity of Illness Index; Toxicology; United States > US

This study is to evaluate the safety and pharmacokinetics (PK) of larsucosterol (DUR-928 or 25HC3S) in subjects with alcohol-associated hepatitis (AH), a devastating acute illness without US Food and Drug Administration-approved therapies. This phase 2a, multicenter, open-label, dose escalation stud...