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A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

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Trial Profile

A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

Status: Recruiting
Phase of Trial: Phase 0

Latest Information Update: 01 Dec 2025

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At a glance

  • Drugs SOF SKN (Primary)
  • Indications Cutaneous lupus erythematosus
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms HERACLES
  • Sponsors Noxopharm

Most Recent Events

  • 10 Nov 2025 According to a Noxopharm media release, participant recruitment is currently ongoing, and the first cohort will receive their first dose in the near future
  • 10 Nov 2025 According to a Noxopharm media release, company announce the start of the second part of the HERACLES clinical trial, following successful single-dose testing.
  • 08 Sep 2025 According to a Noxopharm media release, the safety steering committee has determined the fourth and highest dose level to be safe and well tolerated, with no clinically relevant issues found.

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