Phase 2a, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 2-Part Study to Assess the Safety, Tolerability and Pharmacokinetic Response and Explore the Pharmacodynamic Response Following 4 Weeks of Once Weekly Subcutaneous Injections of PB1046 in Adult Subjects With Stable Heart Failure With Reduced Ejection Fraction (HFrEF) (Part 1) and in Subjects With Cardiac Dysfunction Secondary to Duchenne Muscular Dystrophy (Part 2)

Trial Profile

Phase 2a, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 2-Part Study to Assess the Safety, Tolerability and Pharmacokinetic Response and Explore the Pharmacodynamic Response Following 4 Weeks of Once Weekly Subcutaneous Injections of PB1046 in Adult Subjects With Stable Heart Failure With Reduced Ejection Fraction (HFrEF) (Part 1) and in Subjects With Cardiac Dysfunction Secondary to Duchenne Muscular Dystrophy (Part 2)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 10 May 2017

At a glance

  • Drugs PB 1046 (Primary)
  • Indications Heart failure
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms HFrEF
  • Sponsors PhaseBio Pharmaceuticals
  • Most Recent Events

    • 16 Nov 2016 Planned End Date changed from 1 Feb 2017 to 1 Jun 2017.
    • 16 Nov 2016 Planned primary completion date changed from 1 Feb 2017 to 1 Jun 2017.
    • 08 Aug 2016 According to a PhaseBio Pharmaceuticals media release, first patients in Part One of this trial have been dosed.
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