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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

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: 10 Oct 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

  • 11 Aug 2025 According to a Noxopharm media release,The safety steering committee has determined the second dose level to be safe and tolerable, hence The trial will therefore now proceed to the third cohort of participants, who will receive a higher dose.
  • 11 Aug 2025 According to a Noxopharm media release, the second dose cohort of SOF-SKN™ has been successfully completed in this trial.
  • 20 Jul 2025 Status changed from not yet recruiting to recruiting.

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