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A Randomized, Double-blind, Vehicle-controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intradermally Administered AIV001 in the Healing of Incisional Wounds

Trial Profile

A Randomized, Double-blind, Vehicle-controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intradermally Administered AIV001 in the Healing of Incisional Wounds

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 30 Dec 2024

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At a glance

  • Drugs AIV 001 (Primary)
  • Indications Wounds
  • Focus Adverse reactions
  • Sponsors AiViva BioPharma

Most Recent Events

  • 09 Dec 2024 According to AiViva Biopharma media release, company announced the receipt of FDA clearance for testing AIV001 (axitinib) by intradermal injection with their formulation in facial skin. This FDA clearance was supported by AiViva submission of safety data on non-facial skin tolerability and efficacy, and systemic exposure from 67 subjects treated with AIV001 in BCC and in scar management.
  • 25 Jun 2020 Results presented in an AiViva Biopharma media release.
  • 28 Apr 2020 Status changed from recruiting to completed.

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