A Phase 1/2 Single-ascending and Multiple-ascending Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-CC5 in Healthy Adult Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria.

Trial Profile

A Phase 1/2 Single-ascending and Multiple-ascending Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-CC5 in Healthy Adult Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria.

Completed
Phase of Trial: Phase I/II

Latest Information Update: 08 Sep 2017

At a glance

  • Drugs Cemdisiran (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Adverse reactions; First in man
  • Sponsors Alnylam Pharmaceuticals
  • Most Recent Events

    • 04 Sep 2017 Status changed from active, no longer recruiting to completed.
    • 02 Jun 2017 Planned End Date changed from 1 Dec 2016 to 1 Aug 2017.
    • 06 Dec 2016 Preliminary phase 1/2 study results (part C, n=6) reporting updated tolerability and clinical activity of ALN-CC5 in patients with paroxysmal nocturnal hemoglobinuria, presented at the 58th Annual Meeting and Exposition of the American Society of Hematology.
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