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

NCT03928353 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-05-01

Study results available
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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).

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • SFJ Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • LuAnn Bundrant, MD · PPD Development, LP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2019-10-09
Completion
2019-10-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928353 on ClinicalTrials.gov