Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers
brief summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB2452 (Bentracimab) with and without ticagrelor pretreatment when administered to Chinese healthy male and female subjects. Up to 6 dose levels will be evaluated. This study will have 5 cohorts and a total of 40 subjects with 8 healthy subjects per cohort. Cohort 1 will be split into 3 parts, Cohort 1-a, 1-b and 1-c. The starting dose of PB2452 will be 100 mg and the planned doses for subsequent parts or cohorts are 300, 1000, 3000, 9000, and 18000 mg.
detailed description
The study will consist of a screening period (Days -28 to -4), check-in/pretreatment (Day -3 to -1), an in-house treatment period (Days 1 through 4), and follow-up visits (Days 7 and 28 (+2 days)). Subjects will receive an IV dose of study drug on Day 1.
On Day 1, subjects who meet all of the inclusion criteria and none of the exclusion criteria will be assigned to treatment before dosing. For Cohorts 1-c and 2 to 5, subjects will be randomly assigned to receive PB2452 or placebo in a ratio of 3:1.
official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 (Bentracimab) With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers