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.
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.
Bentracimab (PB2452) 100 mg or Placebo,
Bentracimab (PB2452) 300 mg or Placebo,
Bentracimab (PB2452) 1000 mg or Placebo,
Bentracimab (PB2452) 1000 mg or Placebo (With Ticagrelor Pre-Treatment),
Bentracimab (PB2452) 3000 mg or Placebo (With Ticagrelor Pre-Treatment),
Bentracimab (PB2452) 9000 mg or Placebo (With Ticagrelor Pre-Treatment),
Bentracimab (PB2452) 18000 mg or Placebo (With Ticagrelor Pre-Treatment)
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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