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

A Phase 2B, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversing Ticagrelor in Subjects Aged 50 to 80 Years Old

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ticagrelor Oral Tablet - Pre-Treatment; Drug: Aspirin (ASA) Oral Tablet - Pre-Treatment; Drug: Bentracimab (PB2452) Infusion; Drug: Placebo (0.9% Sodium chloride) infusion

Detailed Description

The study will consist of a Screening period, a Check-in day, an on-site Randomization/Treatment day, a 2-day on-site Follow-up period (Days 2 through 3), a Follow-up visit (Day 7), and a Final Follow-up visit (Day 35±3). If needed and at the discretion of the Investigator, a subject may remain in the study facility beyond the scheduled Day 3 discharge to accommodate Day 7 and Day 35±3 follow-up visits. Seven days prior to enrollment, 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 be randomized with 3:1 allocation ratio (active:placebo), to receive an IV dose of bentracimab (PB2452) or placebo 2 hours following the 5th ticagrelor dose. Subjects may be discharged from the clinical site on Day 3 and will return for a Follow-up visit on Day 7, if already discharged, and on Day 35 (±3 days). A subject may remain in the study facility beyond the scheduled Day 3 discharge to accommodate Day 7 and Day 35±3 follow-up visits.

If a subject is taking a moderate or strong cytochrome P450 3A isozyme (CYP3A) inhibitor, a 36 g alternative regimen of bentracimab (PB2452) will be administered consisting of 12 g infused over 10 minutes followed by a 12 g loading dose infused over 6 hours, then a maintenance dose of 12 g infused over the next 18 hours immediately following completion of the loading period for a total infusion time of approximately 24 hours.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M9L 3A2
      • BioPharma Services Inc.
  • Quebec
    • Mount Royal, Quebec, Canada, H3P 3P1
      • Altasciences Company Inc.
• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest, LLC
  • California
    • Cypress, California, United States, 90630
      • WCCT Global, Inc.
    • San Diego, California, United States, 92103
      • Pacific Research Network
  • Florida
    • Miami, Florida, United States, 33014-3616
      • Clinical Pharmacology of Miami, LLC
    • Orlando, Florida, United States, 32806
      • PPD Development, LP
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Altasciences Clinical Kansas, Inc.
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • BioPharma Services USA Inc. (BPSUSA)
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Inc.
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Inc.
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • VitaLink Research - Greenville
    • Spartanburg, South Carolina, United States, 29303
      • VitaLink Research - Spartanburg
  • Texas
    • Austin, Texas, United States, 78744
      • Rebecca Wood-Horrall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bentracimab (PB2452); PB2452 18 g Intravenous Infusion over a 16 hour duration.	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.
Placebo Comparator: Placebo; Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.	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: Placebo (0.9% Sodium chloride) infusion; 0.9% Sodium chloride Intravenous Infusion over a 16 hour duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Minimum Percent Inhibition Platelet Reactivity Unit (PRU) Assessed by VerifyNow™ PRUTest™ From Baseline to Within 4 Hours After Study Drug Start.	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Baseline (pre-dose) to 4 hours after the start of infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Incidence and severity of AEs		83 days - Starting up to 45 days prior to dosing
Safety - Incidence and severity of adverse events based on physical examination		83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 3, 7, and 35±3
Safety - Incidence of Clinical Laboratory Testing Abnormalities		83 days - Starting up to 45 days prior to dosing, pre-dose and Day 2, 7 and 35±3
Safety - Changes in Systolic Blood Pressure		83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3
Safety - Changes in Diastolic Blood Pressure		83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3
Safety - Changes in Oral Body Temperature		83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3
Safety - Changes in Respiratory Rate		83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3
Safety - Changes in Heart Rate		83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 3, 7, and 35±3
Safety - Incidence of clinically significant findings as measured by 12-Lead ECG		83 days - Starting up to 45 days prior to dosing and collected pre-dose and Days 1, 2, 7, and 35±3
Safety - Incidence of positive testing for Anti-Drug Antibodies		41 days - Starting 3 days prior to dosing and collected post-dose at Day 1, 7 and Day 35±3. May be extended in the event that result does not return to baseline in time allotted.
Cmax Bentracimab (PB2452)	Maximum concentration	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion (exact sample times may be adjusted)
AUC (0-t) Bentracimab (PB2452)	Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
Tmax Bentracimab (PB2452)	Time to maximum concentration	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
AUC0-24 Bentracimab (PB2452)	Area under the plasma concentration versus time curve 0-24 hours	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24 hours after the start of infusion
AUC0-48 Bentracimab (PB2452)	Area under the plasma concentration versus time curve 0-48 hours	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
AUC0-tau Bentracimab (PB2452)	Area under the plasma concentration versus time curve from time zero to the time of the end of the dosing period	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
AUC0-inf Bentracimab (PB2452)	Area under the plasma concentration versus time curve at time 0 extrapolated to infinity	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
t½ Bentracimab (PB2452)	Terminal elimination half-life	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
CL Bentracimab (PB2452)	Clearance	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
Vd Bentracimab (PB2452)	Volume of distribution	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
Cmax (Ticagrelor and Ticagrelor Active Metabolite (TAM))	Maximum concentration	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
AUC0-last (Ticagrelor and Ticagrelor Active Metabolite (TAM))	Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, and 12 hours after the start of infusion
Tmax (Ticagrelor and Ticagrelor Active Metabolite (TAM))	Time to maximum concentration	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
AUC(0-24) (Ticagrelor and Ticagrelor Active Metabolite (TAM))	Area under the plasma concentration versus time curve 0-24 hours	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, and 24 hours after the start of infusion
AUC(0-48) (Ticagrelor and Ticagrelor Active Metabolite (TAM))	Area under the plasma concentration versus time curve 0-48 hours	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
AUC0-tau (Ticagrelor and Ticagrelor Active Metabolite (TAM))	Area under the plasma concentration versus time curve from time zero to the time of the end of the dosing period	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
AUC0-inf (Ticagrelor and Ticagrelor Active Metabolite (TAM))	Area under the plasma concentration versus time curve at time 0 extrapolated to infinity	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
t½ (Ticagrelor and Ticagrelor Active Metabolite (TAM))	Terminal elimination half-life	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36, 48 hours, 7 and 35±3 days after the start of infusion
Ae24 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM))	Total amount of drug excreted in urine at 24 hours	Before dosing and 0 to 6, 6 to 12, and 12 to 24 hours after the initiation of the bentracimab (PB2452) infusion.
Ae48 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM))	Total amount of drug excreted in urine at 48 hours	Before dosing and 0 to 6, 6 to 12, 12 to 24 and 24 to 48 hours after the initiation of the bentracimab (PB2452) infusion
Aet1-t2 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM))	Total amount of drug excreted in urine from time t1 to t2 hours	Before dosing and 0 to 6, 6 to 12, 12 to 24 and 24 to 48 hours after the initiation of the bentracimab (PB2452) infusion
Fe24 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM))	Fraction excreted in urine from 1 to 24 hours	Before dosing and 0 to 6, 6 to 12, and 12 to 24 hours after the initiation of the bentracimab (PB2452) infusion and 5th ticagrelor dose.
Fe48 (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM))	Fraction excreted in urine from 1 to 48 hours	Before dosing and 0 to 6, 6 to 12, 12 to 24 and 24 to 48 hours after the initiation of the bentracimab (PB2452) infusion and 5th ticagrelor dose
CLr (Urine - Ticagrelor and Ticagrelor Active Metabolite (TAM))	Renal clearance	Before dosing and 0 to 6, 6 to 12, and 12 to 24 hours after the initiation of the bentracimab (PB2452) infusion and 5th ticagrelor dose
Reversal effects of intravenous infusion of bentracimab (PB2452) compared to baseline - Minimum % inhibition of PRI (VASP)	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 4 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) compared to baseline - PRU (Verify Now) AUC	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 4 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % of subjects to ≥ 180 PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and 4 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % of subjects to ≥ 60% of reversal in PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % of subjects to ≥ 80% of reversal in PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % of subjects to ≥ 100% of reversal in PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Time to ≥ 60% of reversal by PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Time to ≥ 80% of reversal by PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Time to ≥ 100% of reversal by PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Duration of 80% response rate by PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Duration of 100% response rate by PRU	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - PRI AUC	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 4 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % of subjects with ≥ 60% PRI response rate within 4 hours	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 4 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % of subjects with ≥ 80% PRI response rate within 4 hours	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 4 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % of subjects with ≥ 100% PRI response rate within 4 hours	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 4 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Time to ≥ 60% of reversal by PRI	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Time to ≥ 80% of reversal by PRI	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Time to ≥ 100% of reversal by PRI	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Duration of 80% response rate by PRI	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - Duration of 100% response rate by PRI	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and at 5, 10 and 30 minutes, 1, 2, 4, 8, 12, 20, 24, 36 and 48 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % Reversal of PRU within 4 hours	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and 4 hours after the start of infusion
Reversal effects of intravenous infusion of bentracimab (PB2452) - % Reversal of PRI within 4 hours	Reversal of anti-platelet effects of ticagrelor with intravenous infusion of bentracimab (PB2452) or placebo	Before dosing and 4 hours after the start of infusion

Collaborators and Investigators

• Sponsor: SFJ Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Ticagrelor
• Other Study ID Numbers: PB2452-PT-CL-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No