Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers
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
Outcome
Outcome not reported
Stopped (Enrollment): “After recruitment of Cohorts 1-4 was completed, Sponsor decided to terminate study, initially due to COVID and then considering that PK data from the dose planned to be tested in Cohort 5 (18000 mg) would be available from the ongoing Phase 3 study.”
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.