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Monoclonal Antibodies

Bentracimab (PB2452) for Healthy Subjects

Phase 2
Waitlist Available
Research Sponsored by SFJ Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Summary

This trial is designed to see if the investigational drug, PB2452, is effective in reversing the anti-platelet effects of ticagrelor, and if it is safe and well tolerated in subjects aged 50 to 80 years old. A total of 205 subjects will be enrolled at sites across the US and other countries, with154 receiving the PB2452 drug and 51 receiving placebo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of Minimum Percent Inhibition Platelet Reactivity Unit (PRU) Assessed by VerifyNow™ PRUTest™ From Baseline to Within 4 Hours After Study Drug Start.
Secondary study objectives
AUC (0-t) Bentracimab (PB2452)
Ticagrelor
AUC(0-48) (Ticagrelor and Ticagrelor Active Metabolite (TAM))
+53 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Bentracimab (PB2452)Active Control3 Interventions
PB2452 18 g Intravenous Infusion over a 16 hour duration.
Group II: PlaceboPlacebo Group3 Interventions
Placebo (0.9% Sodium chloride) intravenous Infusion over a 16 hour duration.

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Who is running the clinical trial?

SFJ Pharmaceuticals, Inc.Lead Sponsor
6 Previous Clinical Trials
982 Total Patients Enrolled
PhaseBio Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
1,328 Total Patients Enrolled
~35 spots leftby Sep 2025
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