NCT05162131

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 (Bentracimab) With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: SFJ Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Bentracimab (PB2452) 100 mg or Placebo	Experiment 1-a: 100 mg Bentracimab (PB2452) (no Placebo, no Ticagrelor) Drug: PB2452 infusion 30 minute - 12-hour infusion
DRUG	Bentracimab (PB2452) 300 mg or Placebo	Experiment 1-b: 300 mg Bentracimab (PB2452) (no Placebo, no Ticagrelor) Drug: PB2452 infusion 30 minute - 12-hour infusion
DRUG	Bentracimab (PB2452) 1000 mg or Placebo	Experiment 1-c: 1000 mg Bentracimab (PB2452) or Placebo (no Ticagrelor) Drug: PB2452 Infusion 30 minute - 12-hour infusion Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion
DRUG	Bentracimab (PB2452) 1000 mg or Placebo (With Ticagrelor Pre-Treatment)	Experiment 2: 1000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment) Drug: PB2452 infusion 30 minute - 12-hour infusion Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion Drug: Ticagrelor Oral Tablet - Pre-treatment Ticagrelor 180 mg + 90 mg bid for 5 doses prior to PB2452 or Placebo
DRUG	Bentracimab (PB2452) 3000 mg or Placebo (With Ticagrelor Pre-Treatment)	Experiment 3: 3000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment) Drug: PB2452 infusion 30 minute - 12-hour infusion Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion Drug: Ticagrelor Oral Tablet - Pre-treatment Ticagrelor 180 mg + 90 mg bid for 5 doses prior to PB2452 or Placebo
DRUG	Bentracimab (PB2452) 9000 mg or Placebo (With Ticagrelor Pre-Treatment)	Experiment 4: 9000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment) Drug: PB2452 infusion 30 minute - 12-hour infusion Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion Drug: Ticagrelor Oral Tablet - Pre-treatment Ticagrelor 180 mg + 90 mg bid for 5 doses prior to PB2452 or Placebo
DRUG	Bentracimab (PB2452) 18000 mg or Placebo (With Ticagrelor Pre-Treatment)	Experiment 5: 18000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment) Drug: PB2452 infusion 30 minute - 12-hour infusion Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion Drug: Ticagrelor Oral Tablet - Pre-treatment Ticagrelor 180 mg + 90 mg bid for 5 doses prior to PB2452 or Placebo

Timeline

• Start date: 2021-12-25
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2021-12-17
• Last updated: 2024-01-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study