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Phase 1/2 double-blind, placebo-controlled single ascending dose study of BJT-778 in healthy volunteers and subjects with chronic hepatitis B (CHB) and chronic hepatitis D infection (CHD)

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Trial Profile

Phase 1/2 double-blind, placebo-controlled single ascending dose study of BJT-778 in healthy volunteers and subjects with chronic hepatitis B (CHB) and chronic hepatitis D infection (CHD)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Aug 2024

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At a glance

  • Drugs BJT 778 (Primary)
  • Indications Hepatitis B; Hepatitis D
  • Focus Adverse reactions

    • Most Recent Events

    • 29 May 2024 According to a Bluejay Therapeutics media release, company today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Company's application for orphan designation for BJT-778 for the treatment of chronic hepatitis D (CHD).
    • 22 May 2024 According to a Bluejay Therapeutics media release, results form this trial will be presented at the European Association for the Study of the Liver (EASL) conference taking place June 5-8, in Milan, Italy.
    • 25 Mar 2024 According to a Bluejay Therapeutics media release, the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection. The application for PRIME designation was bolstered by compelling data from non-clinical studies, along with interim results from the company's Phase 1/2 study that included subjects with chronic HDV.

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