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

• Status: Completed
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of PB2452 in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of PB2452 in subjects aged 50-80 years old.

Approximately 200 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 PB2452 investigational study drug or placebo. Hence, a total of approximately 150 subjects will be receiving PB2452 and approximately 50 subjects will be receiving placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PhaseBio Pharmaceuticals Inc.
• Treatments: Aspirin; Ticagrelor

Criteria

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 PB2452 or had been randomized to receive study drug in an earlier cohort for this study