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A Phase I Randomised, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect of Food on the Bioavailability of SKY-0515 in Healthy Volunteers and Patients with Huntington's Disease

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Trial Profile

A Phase I Randomised, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect of Food on the Bioavailability of SKY-0515 in Healthy Volunteers and Patients with Huntington's Disease

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs SKY 0515 (Primary)
  • Indications Huntington's disease
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors Skyhawk Therapeutics

Most Recent Events

  • 15 Mar 2025 According to a Skyhawk Therapeutics media release, the study will be presented at the biannual HYDO International Congress in Prague, Czech Republic
  • 09 Dec 2024 According to Skyhawk Therapeutics media release, the Australian Human Research Ethics Committees (HREC) have approved SKY-0515 treatment duration for up to 12 weeks in this study
  • 11 Sep 2024 According to a Skyhawk Therapeutics media release, company announced that additional positive topline data from Parts A and B of this trial will be presented at the European Huntington's Disease Network and Enroll-HD 2024 meeting to be held from September 12-14, 2024 in Strasbourg, France.

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