Phase 2B Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversal of Ticagrelor in Subjects Aged 50-80 Years Old

PHASE2CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

September 24, 2019

Primary Completion Date

September 1, 2021

Study Completion Date

September 1, 2021

Conditions
Healthy
Interventions
DRUG

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.

DRUG

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.

DRUG

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."

DRUG

Placebo (0.9% Sodium chloride) infusion

0.9% Sodium chloride Intravenous Infusion over a 16 hour duration

Trial Locations (15)

28112

Monroe Biomedical Research, Monroe

29303

VitaLink Research - Spartanburg, Spartanburg

29615

VitaLink Research - Greenville, Greenville

32806

PPD Development, LP, Orlando

43213

Aventiv Research Inc., Columbus

43215

Remington-Davis, Inc., Columbus

63141

BioPharma Services USA Inc. (BPSUSA), St Louis

66212

Altasciences Clinical Kansas, Inc., Overland Park

72758

Woodland Research Northwest, LLC, Rogers

78744

Rebecca Wood-Horrall, Austin

90630

WCCT Global, Inc., Cypress

92103

Pacific Research Network, San Diego

33014-3616

Clinical Pharmacology of Miami, LLC, Miami

M9L 3A2

BioPharma Services Inc., Toronto

H3P 3P1

Altasciences Company Inc., Mount Royal

All Listed Sponsors
lead

SFJ Pharmaceuticals, Inc.

INDUSTRY

NCT04122170 - Phase 2B Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversal of Ticagrelor in Subjects Aged 50-80 Years Old | Biotech Hunter | Biotech Hunter