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This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of PB2452 in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of PB2452 in subjects aged 50-80 years old.
Approximately 200 subjects between 50-80 years old will be enrolled across the US or other countries across 5-15 sites. The subjects will be randomized at a ratio of 3:1 receiving either the PB2452 investigational study drug or placebo. Hence, a total of approximately 150 subjects will be receiving PB2452 and approximately 50 subjects will be receiving placebo.
The study will consist of a Screening period, a Check-in day and Pretreatment Period, an on-site Randomization/Treatment day, a Follow-up Visit (Day 7), and a Final Follow-up visit (Day 35). Seven days prior to Randomization, subjects will be administered ASA 81 mg orally once daily (QD) until the final dose on Day 1. Beginning in the morning on Day -2, a single dose of oral ticagrelor 180 mg will be given, followed by oral ticagrelor 90 mg every 12 hours for 4 additional doses through to Day 1 (2 hours before study drug is initiated; this will be 5 total doses of ticagrelor).
On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria will randomized with 3:1 allocation ratio (active:placebo), to receive an IV dose of PB2452 or placebo 2 hours following the 5th ticagrelor dose. Subjects may be discharged from the clinical site between Days 3 and 7 inclusive and will return for a Follow-up visit on Day 7, if already discharged, and on Day 35 (±3 days).
Ticagrelor Oral Tablet - Pre-Treatment, Aspirin (ASA) Oral Tablet - Pre-Treatment, PB2452 Infusion, Placebo (0.9% Sodium chloride) infusion
PPD Development, LP
PhaseBio Pharmaceuticals Inc.
Published on BioPortfolio: 2019-10-16T10:39:35-0400
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