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A Phase 1a/1b, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of ABI-5366 in Healthy Subjects and in Subjects Who Are Seropositive for Herpes Simplex Virus Type 2 With Recurrent Genital Herpes

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Trial Profile

A Phase 1a/1b, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of ABI-5366 in Healthy Subjects and in Subjects Who Are Seropositive for Herpes Simplex Virus Type 2 With Recurrent Genital Herpes

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Aug 2025

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At a glance

  • Drugs ABI 5366 (Primary)
  • Indications Herpes genitalis; Herpes simplex virus type 2 infections
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Sponsors Assembly Biosciences

Most Recent Events

  • 28 Jul 2025 Planned End Date changed from 1 Jul 2025 to 1 Dec 2025.
  • 28 Jul 2025 Planned primary completion date changed from 1 Jul 2025 to 1 Dec 2025.
  • 26 Jul 2025 According to an Assembly Biosciences media release, data from this trial are featured in multiple poster presentations, including one late-breaker, during the STI & HIV 2025 World Congress, taking place July 26-30, 2025, in Montreal, Canada, as well as in oral and poster presentations at the 49th Annual International Herpesvirus Workshop, taking place July 26-30, 2025, in Berlin, Germany.

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