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Four-part, Randomized, Double-blind (Parts 1, 2A, 3 and 4), Multi-center, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK3965193 Monotherapy in Healthy Participants and in Participants Living With Chronic Hepatitis B Infection; and GSK3965193 in Combination With Bepirovirsen in Participants Living With Chronic Hepatitis B Infection

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Trial Profile

Four-part, Randomized, Double-blind (Parts 1, 2A, 3 and 4), Multi-center, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK3965193 Monotherapy in Healthy Participants and in Participants Living With Chronic Hepatitis B Infection; and GSK3965193 in Combination With Bepirovirsen in Participants Living With Chronic Hepatitis B Infection

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Nov 2024

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At a glance

  • Drugs Bepirovirsen (Primary) ; GSK 3965193 (Primary)
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 12 Nov 2024 Planned End Date changed from 1 Jan 2026 to 6 Oct 2027.
    • 12 Nov 2024 Planned primary completion date changed from 1 Jan 2026 to 6 Oct 2027.
    • 08 Nov 2024 Arms increased from 8 to 9. Treatment arm 'Experimental: Part 3 Sub-Cohort 7: Open label bepirovirsen' added newly. Primary endpoints updated.

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