drugset / Trial / NCT03492385
Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 in Healthy Volunteers
RandomizedSequentialQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-04-03
- Primary completion
- 2018-09-18
- Completion
- 2018-09-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.