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An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

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Trial Profile

An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 15 May 2025

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At a glance

Most Recent Events

  • 08 May 2025 According to a GH Research media release, This trial is designed to support our global program for GH001, by bridging to the clinical data generated with the commercially available device that we have used in our clinical trials to date.
  • 10 Jan 2025 According to a GH Research media release, the company's response to FDA's request for additional device design verification information is being prepared.
  • 10 Jan 2025 According to a GH Research media release, the IND for proprietary aerosol delivery device for GH-001 has been placed on clinical hold by the U.S. Food and Drug Administration (FDA), to resolve which FDA requires (i) an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, (ii) additional device design verification information and (iii) updates to our investigator brochure. The toxicology studies in non-rodents (dogs) and rats are completed.

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