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.

Conditions

• Healthy

Interventions

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

Sponsors & Collaborators

• SFJ Pharmaceuticals, Inc.

  lead INDUSTRY

Principal Investigators

• Dong Ruihua · Beijing Friendship Hospital, 101 Luyuan Est. Rd., Tongzhou District, Beijing, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

20 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-25

Primary Completion

2022-12-30

Completion

2022-12-30

FDA Drug

Yes

Countries

• China

Study Locations