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A Phase 1/2, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.

Trial Profile

A Phase 1/2, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs ALN AAT (Primary)
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Adverse reactions; First in man
  • Sponsors Alnylam Pharmaceuticals

Most Recent Events

  • 15 Mar 2018 Status changed from active, no longer recruiting to discontinued due to observation of low incidence of asymptomatic, transiently elevated liver enzymes in a subset of study subjects
  • 22 Nov 2017 Planned number of patients changed from 66 to 26.
  • 22 Nov 2017 Planned End Date changed from 1 Nov 2017 to 1 Feb 2018.

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