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A Phase 1, Single-ascending Dose, Multiple-ascending Dose, and Multi-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN AS1 in Patients With Acute Intermittent Porphyria (AIP)

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Trial Profile

A Phase 1, Single-ascending Dose, Multiple-ascending Dose, and Multi-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN AS1 in Patients With Acute Intermittent Porphyria (AIP)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Givosiran (Primary)
  • Indications Acute intermittent porphyria
  • Focus Adverse reactions; First in man
  • Acronyms EXPLORE
  • Sponsors Alnylam Pharmaceuticals

    • Most Recent Events

    • 29 Jan 2020 Results, assessing the pharmacokinetics and pharmacodynamics relationship of givosiran, published in the Clinical Pharmacology and Therapeutics
    • 14 Aug 2019 According to an Alnylam Pharmaceuticals media release, results from this study will be presented at the 2019 International Congress on Porphyrins and Porphyria (ICPP).
    • 16 Mar 2019 Results presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics

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