NCT03928353

Study to Evaluate the Safety, Tolerability, PK and PD of PB2452 in Healthy Younger, Older and Elderly Subjects

A Phase 2A, Randomized, Double-blind, Placebo-controlled, Single Dose, Sequential Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 With Ticagrelor Pretreatment in Older and Elderly Subjects and With High-Dose Ticagrelor Pretreatment in Healthy Younger Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: SFJ Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2A, randomized, double-blind, placebo-controlled, single dose, sequential group study to evaluate the safety, tolerability, PK, and PD of PB2452 vs matching placebo with ticagrelor (with or without acetylsalicylic acid (ASA)) pretreatment when various dose levels and administration regimens are administered to healthy younger (ages 18 to 50), older (ages 50 to 64 years) and elderly (ages 65 to 80 years) male and female subjects. Up to 5 dose levels and/or administration regimens will be evaluated in up to 5 cohorts. Each cohort will include approximately 8 to 12 subjects randomized in a 3:1 ratio (PB2452:placebo).

Detailed description

The study will consist of a Screening period, a Check-in day and Pretreatment Period, an on-site Randomization/Treatment day, 3 days on-site for treatment and safety monitoring, a Follow-up Visit (Day 7), and a Final Follow-up visit (Day 28). Seven days prior to Randomization, subjects in Cohorts 1 and 2 will be administered acetylsalicylic acid (ASA) 81 mg orally once daily (QD) until the final dose on the morning of Day 1 before receiving study drug. A ticagrelor 180 mg oral dose will be administered on the morning of Day -2 followed by either 90 mg or 180 mg every 12 hours (BID) until the 5th dose has been administered on the morning of Day 1. On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a ratio 3:1 (PB2452:placebo), to receive an IV dose of PB2452 or placebo 2 hours following the 5th ticagrelor dose. Subjects may be discharged from the clinical site between Days 3 and 7 inclusive and will return for a Follow-up visit on Day 7, if already discharged, and on Day 28 (±2 days).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PB2452 Infusion	30 minute - 24 hour infusion
DRUG	Placebo - Sodium Chloride	30 minute - 24 hour infusion
DRUG	Ticagrelor Oral Tablet - Pre-Treatment	Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo
DRUG	Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment	Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo and Ticagrelor 180 mg 24 hours following PB2452 or Placebo
DRUG	Ticagrelor Oral Tablet - Pre-Treatment	Ticagrelor 180 mg BID for 5 doses prior to PB2452 or Placebo
DRUG	PB2452 Infusion	30 minute - 16 hour infusion
DRUG	Placebo - Sodium Chloride	Placebo - Sodium Chloride

Timeline

• Start date: 2019-04-16
• Primary completion: 2019-10-09
• Completion: 2019-10-09
• First posted: 2019-04-26
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study