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A Phase 1 study with IN-001 in healthy volunteers

Trial Profile

A Phase 1 study with IN-001 in healthy volunteers

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2020

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At a glance

  • Drugs Dipivefrine (Primary) ; Epinephrine
  • Indications Anaphylaxis
  • Focus Adverse reactions
  • Most Recent Events

    • 05 Nov 2020 New trial record
    • 29 Oct 2020 According to an Insignis Therapeutics media release, if this study is successful, under the 505(b)(2) regulatory pathway, Insignis and HLK Pharmacin would begin preparations to initiate a pivotal study in the second half of 2021.
    • 29 Oct 2020 According to an Insignis Therapeutics media release, the company and HLK Pharmacin announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IN-001, an oral formulation of an epinephrine prodrug for life-saving treatment of allergic reactions, including anaphylaxis. Under this IND, the companies are prepared to initiate a Phase 1 study this quarter and intends to have clinical data in first half of 2021.
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