drugset
drugset / Trial / NCT03928353

Study to Evaluate the Safety, Tolerability, PK and PD of PB2452 in Healthy Younger, Older and Elderly Subjects

NCT03928353 ↗

Phase 2 Completed 23 enrolled SFJ Pharmaceuticals, Inc.
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a Phase 2A, randomized, double-blind, placebo-controlled, single dose, sequential group study to evaluate the safety, tolerability, PK, and PD of PB2452 vs matching placebo with ticagrelor (with or without acetylsalicylic acid (ASA)) pretreatment when various dose levels and administration regimens are administered to healthy younger (ages 18 to 50), older (ages 50 to 64 years) and elderly (ages 65 to 80 years) male and female subjects. Up to 5 dose levels and/or administration regimens will be evaluated in up to 5 cohorts. Each cohort will include approximately 8 to 12 subjects randomized in a 3:1 ratio (PB2452:placebo).

Timeline

Start
2019-04-16
Primary completion
2019-10-09
Completion
2019-10-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Bentracimab Monoclonal antibody 18 g Intravenous
Subject Ticagrelor Small molecule 90 mg Oral
Subject Ticagrelor Small molecule 180 mg Oral

Indications

No indication recorded.