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A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Subjects (Part I), and After Multiple Dose Regimens in Subjects With Chronic Hepatitis B (Part II)

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Trial Profile

A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Subjects (Part I), and After Multiple Dose Regimens in Subjects With Chronic Hepatitis B (Part II)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Sep 2021

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At a glance

  • Drugs Bersacapavir (Primary)
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Janssen Sciences Ireland UC

    • Most Recent Events

    • 25 Apr 2020 Results published in the Gastroenterology
    • 02 Jul 2019 Results (n=30) evaluating the pharmacokinetics, safety and tolerability of single and multiple asceding doses of JNJ-6379 published in the Advances in Therapy
    • 13 Nov 2018 Results assessing the safety, pharmacokinetics and antiviral activity of multiple doses of JNJ-6379 in Part 2 of the study, presented at The Liver Meeting 2018: 69th Annual Meeting of the American Association for the Study of Liver Diseases
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