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A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in Healthy Volunteer Subjects

Trial Profile

A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in Healthy Volunteer Subjects

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 02 Dec 2021

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At a glance

  • Drugs Rencofilstat (Primary) ; Tenofovir disoproxil fumarate (Primary)
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man
  • Sponsors Hepion Pharmaceuticals
  • Most Recent Events

    • 30 Nov 2021 Status changed from recruiting to completed.
    • 29 Jun 2020 According to a Hepion Pharmaceuticals media release, the company completed evaluation of CRV 431 as single dose at 75mg, 150mg, 225mg and 300mg in healthy volunteers. Based on available safety and tolerability data and no observable dose-limiting side effects at 300mg dose, the company initiated the evaluation of safety, tolerability and pharmacokinetics of CRV 431 at 375mg, daily for 28 days in healthy volunteers.
    • 29 Jun 2020 Interim results presented in a Hepion Pharmaceuticals Media Release.
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