drugset
drugset / Trial / NCT05162131

Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers

NCT05162131 ↗

Phase 1 Terminated 34 enrolled SFJ Pharmaceuticals, Inc.
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2021-12-25
Primary completion
2022-12-30
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bentracimab Monoclonal antibody 100 mg Intravenous
Subject Bentracimab Monoclonal antibody 300 mg Intravenous
Subject Bentracimab Monoclonal antibody 1000 mg Intravenous
Subject Bentracimab Monoclonal antibody 3000 mg Intravenous
Subject Bentracimab Monoclonal antibody 9000 mg Intravenous
Subject Bentracimab Monoclonal antibody 18000 mg Intravenous
Background Ticagrelor Small molecule 90 mg Oral

Indications

No indication recorded.