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

Completed · Phase 2 · Has a placebo group

Conditions studied: Healthy

In brief

This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of bentracimab (PB2452) in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of bentracimab (PB2452) in subjects aged 50-80 years old. A total of 205 subjects between 50-80 years old will be enrolled in the US or other countries at the discretion of the Sponsor across 5-15 sites. The subjects will be randomized at a ratio of 3:1 receiving either the bentracimab (PB2452) investigational study drug or placebo. Hence, a total of 154 subjects will be receiving bentracimab (PB2452) and approximately 51 subjects will be receiving placebo.

Key facts

Study ID: NCT04122170
Run by: SFJ Pharmaceuticals, Inc.
People needed: 207
Starts: 2019-09-24
Expected to finish: 2021-09-01
Last updated by the study team: 2024-04-08

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

The subject provides written or verbal informed consent (in-person or remotely) and agrees to comply with all protocol requirements throughout study participation.
The subject is male or female between ≥50 and ≤80 years of age.
The subject has a body mass index between 18 and 35 kg/m2 and a weight of ≥ 50 kg but ≤ 120 kg, inclusive, at screening.
The subject is considered by the Investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination findings at screening and Check-in. Subjects with chronic, stable, and well-controlled medical conditions, are eligible provided they meet all other inclusion/exclusion criteria.
The subject has specific inclusionary laboratory values at screening and check-in: white blood cell (WBC) count, platelet count, haemoglobin level, thyroid-stimulating hormone (TSH) level, and prothrombin time (PT) and partial thromboplastin time (PTT) levels within the normal range.
Subjects taking medications for well-controlled medical conditions must have been on a stable dose for at least 30 days prior to screening visit.
Subjects entering the study must be willing to start and/or document an 81 mg daily dose of aspirin on Day -7 and must document daily dosing until the final dose is administered on the morning of Day 1. Subjects already taking daily aspirin must suspend aspirin dosing after Day 1 until discharge from the clinical facility.
Female subjects of childbearing potential must not be pregnant, lactating, or planning to become pregnant for 3 months after the last dose of study drug. Female subjects of childbearing potential must use two effective methods of birth control from screening and before study drug administration through to the end of the study.

You may not qualify if…

In the opinion of the Investigator there are concern(s) regarding the inability of the subject to comply with study procedures and/or follow up, or, if the subject is not suitable for entry into the study.
History of any acute or chronic medical disorder expected to decrease the life expectancy of the subject to an extent where the subject's study participation is affected.
Any clinically significant acute illness, medical/surgical procedure, or trauma within 4 weeks of the administration of study drug or any planned surgical procedure that will occur during the study.
Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments, and ECG parameters identified during screening or check-in.
Any specific contraindication to ticagrelor as described in the ticagrelor prescribing information.
Receiving chronic treatment with nonsteroidal anti-inflammatory drugs [including aspirin (>100 mg daily), anticoagulants, or other antiplatelet agents that cannot be discontinued 14 days prior to screening including clopidogrel, prasugrel, ticlopidine, dipyridamole, or cilostazol].
First positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
Has received another investigational drug within 30 days of the administration of study drug in this study or within 5 half-lives of the experimental medication, whichever is longer.
History of severe or ongoing allergy/hypersensitivity to any biologic therapeutic agent.
Involvement with any PhaseBio or study site employee or their close relatives (e.g., spouse, parents, siblings, or children whether biological or legally adopted).
Previously received Bentracimab (PB2452) or had been randomized to receive study drug in an earlier cohort for this study

Where it is running

Woodland Research Northwest, LLC — Rogers, Arkansas, United States
WCCT Global, Inc. — Cypress, California, United States
Pacific Research Network — San Diego, California, United States
Clinical Pharmacology of Miami, LLC — Miami, Florida, United States
PPD Development, LP — Orlando, Florida, United States
Altasciences Clinical Kansas, Inc. — Overland Park, Kansas, United States
BioPharma Services USA Inc. (BPSUSA) — St Louis, Missouri, United States
Monroe Biomedical Research — Monroe, North Carolina, United States
Aventiv Research Inc. — Columbus, Ohio, United States
Remington-Davis, Inc. — Columbus, Ohio, United States
VitaLink Research - Greenville — Greenville, South Carolina, United States
VitaLink Research - Spartanburg — Spartanburg, South Carolina, United States
Rebecca Wood-Horrall — Austin, Texas, United States
BioPharma Services Inc. — Toronto, Ontario, Canada
Altasciences Company Inc. — Mount Royal, Quebec, Canada

Full record on ClinicalTrials.gov

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