Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 in Healthy Volunteers
Status:
Completed
Trial end date:
2018-09-18
Target enrollment:
Participant gender:
Summary
This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single
ascending dose, sequential group study to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of PB2452 with and without ticagrelor pretreatment
when administered to healthy male and female subjects.
Up to 6 dose levels will be evaluated. This study will have up to 10 cohorts and up to a
total of approximately 76 subjects with either 4 or 8 healthy young subjects in Cohorts 1
through 9 or approximately 16 older subjects in Cohort 10. The starting dose of PB2452 will
be 100 mg and the planned doses for subsequent cohorts are 300, 1000, 3000, 9000, and 18000
mg.