A Sequential Phase 1a/1b Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ARC-521 in Normal Adult Volunteers and Patients With Chronic Hepatitis B

Trial Profile

A Sequential Phase 1a/1b Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ARC-521 in Normal Adult Volunteers and Patients With Chronic Hepatitis B

Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 20 Apr 2017

At a glance

  • Drugs ARC 521 (Primary)
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Arrowhead Pharmaceuticals
  • Most Recent Events

    • 20 Apr 2017 According to an Arrowhead Pharmaceuticals media release, clinical data was presented at The International Liver Congress 2017 (ILC), the annual meeting of the European Association for the Study of the Liver (EASL).
    • 29 Nov 2016 Arrowhead Pharmaceuticals discontinued the development of ARC-521 based upon the discussion with the regulatory agencies regarding the substantial delays in all clinical programs that utilize EX1 and secondly, company has made substantial advances in RNA chemistry and targeting resulting in large potency gains for subQ administered and extra-hepatic RNAi-based development programs. Patients recruitment has been halted and dosing discontinued.
    • 29 Nov 2016 Status changed from recruiting to discontinued, as per an Arrowhead Pharmaceuticals media release.
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