At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2A, Randomized, Double-blind, Placebo-controlled, Single Dose, Sequential Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 With Ticagrelor Pretreatment in Older and Elderly Subjects and With High-Dose Ticagrelor Pretreatment in Healthy Younger Subjects
In Brief
A Phase 2 clinical trial evaluating PB2452 Infusion, Placebo - Sodium Chloride, and 2 other interventions for Healthy. Completed, enrolled 23 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
30 minute - 24 hour infusion
30 minute - 24 hour infusion
Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo
Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo and Ticagrelor 180 mg 24 hours following PB2452 or Placebo
Ticagrelor 180 mg BID for 5 doses prior to PB2452 or Placebo
30 minute - 16 hour infusion
Placebo - Sodium Chloride