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A Combined Single and Multiple Ascending Dose Phase 1a/1b, Double-blind, Placebo-Controlled, and Food-effect Study to Evaluate the Safety and Pharmacokinetics of Oral KM-023 in Healthy Participants. Followed by a 3-month Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral KM-023 in Olmsted Syndrome Patients

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Trial Profile

A Combined Single and Multiple Ascending Dose Phase 1a/1b, Double-blind, Placebo-Controlled, and Food-effect Study to Evaluate the Safety and Pharmacokinetics of Oral KM-023 in Healthy Participants. Followed by a 3-month Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral KM-023 in Olmsted Syndrome Patients

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Apr 2026

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At a glance

  • Drugs Ainuovirine (Primary)
  • Indications Congenital disorders; Palmoplantar keratoderma; Skin disorders
  • Focus Adverse reactions; First in man
  • Sponsors Orvida Pharma

Most Recent Events

  • 15 Apr 2026 According to Kamari Pharma media release, company has also initiated the Phase 1b portion of the study in patients with Olmsted syndrome, and the first patient has been dosed. topline results are expected in the third quarter of 2026.
  • 15 Apr 2026 Results presented in the Kamari Pharma Media Release
  • 03 Jun 2025 According to Kamari Pharma media release, company announced the closing of a $23 million Series A financing. The round was co-led by new investor BRM Group and existing investor Pontifax with participation from additional investors. Proceeds will be used to advance lead program KM023 a first-in-class oral TRPV3 inhibitor, into clinical development for the treatment of three rare genetic skin diseases, Olmsted syndrome, severe keratoderma and ichthyosis.

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