Study to Evaluate the Safety, Tolerability, PK and PD of PB2452 in Healthy Younger, Older and Elderly Subjects
Status:
Completed
Trial end date:
2019-10-09
Target enrollment:
Participant gender:
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).