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A two-part phase 1 study to assess the safety, tolerability and pharmacokinetics of UNI-494 with an optional third-part to assess the relative bioavailability compared to nicorandil in healthy male and female subjects

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Trial Profile

A two-part phase 1 study to assess the safety, tolerability and pharmacokinetics of UNI-494 with an optional third-part to assess the relative bioavailability compared to nicorandil in healthy male and female subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Oct 2025

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At a glance

  • Drugs UNI 494 (Primary) ; Nicorandil
  • Indications Acute kidney injury
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Acronyms QSC207400
  • Sponsors Unicycive Therapeutics

Most Recent Events

  • 18 Aug 2025 Status changed to completed.
  • 13 Mar 2024 According to an Unicycive Therapeutics media release, company is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in 2H of 2024.
  • 13 Mar 2024 According to an Unicycive Therapeutics media release, poster, entitled, UNI-494 Phase 1 Safety, Tolerability and Pharmacokinetics: Trial in Progress, were presented on March 12, 2024 at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024.

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