Safety, Tolerability, and Pharmacokinetics of ARC‐520 Injection, an RNA Interference‐Based Therapeutic for the Treatment of Chronic Hepatitis B Virus Infection, in Healthy Volunteers

• Published in: Clinical pharmacology in drug development Vol. 6; no. 4; pp. 350 - 362
• Main Authors: Schluep, Thomas, Lickliter, Jason, Hamilton, James, Lewis, David L., Lai, Ching‐Lung, Lau, Johnson YN, Locarnini, Stephen A., Gish, Robert G., Given, Bruce D.
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.07.2017; John Wiley and Sons Inc
• Subjects: Adult; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Antiviral Agents - pharmacokinetics; Cytokines; Double-Blind Method; Female; Half-Life; Healthy Volunteers; Hepatitis; Hepatitis B; Hepatitis B, Chronic - drug therapy; Histamine; Histamine Antagonists - administration & dosage; Humans; Infusions, Intravenous; Male; Middle Aged; Original; Pharmacokinetics; Pharmacology; phase 1; Pre-Exposure Prophylaxis - methods; RNA Interference; RNAi; safety; tolerability; treatment; viral hepatitis; volunteers; Young Adult; treatment; viral hepatitis; RNAi; phase 1; RNA interference; hepatitis B; safety; pharmacology; tolerability; pharmacokinetics; volunteers

ARC‐520 Injection, an RNA interference drug for the treatment of hepatitis B that targets cccDNA‐derived viral mRNA transcripts with high specificity, effectively reduces the production of viral proteins and HBV DNA. In this phase 1 randomized, double‐blind, placebo‐controlled study, 54 healthy volu...