207
Participants
Start Date
September 24, 2019
Primary Completion Date
September 1, 2021
Study Completion Date
September 1, 2021
Ticagrelor Oral Tablet - Pre-Treatment
Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin (ASA) Oral Tablet - Pre-Treatment
Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Bentracimab (PB2452) Infusion
"Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration~In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion."
Placebo (0.9% Sodium chloride) infusion
0.9% Sodium chloride Intravenous Infusion over a 16 hour duration
Monroe Biomedical Research, Monroe
VitaLink Research - Spartanburg, Spartanburg
VitaLink Research - Greenville, Greenville
PPD Development, LP, Orlando
Aventiv Research Inc., Columbus
Remington-Davis, Inc., Columbus
BioPharma Services USA Inc. (BPSUSA), St Louis
Altasciences Clinical Kansas, Inc., Overland Park
Woodland Research Northwest, LLC, Rogers
Rebecca Wood-Horrall, Austin
WCCT Global, Inc., Cypress
Pacific Research Network, San Diego
Clinical Pharmacology of Miami, LLC, Miami
BioPharma Services Inc., Toronto
Altasciences Company Inc., Mount Royal
SFJ Pharmaceuticals, Inc.
INDUSTRY