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Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 in Healthy Volunteers

NCT03492385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-11-04

Study results available
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Summary

This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB2452 with and without ticagrelor pretreatment when administered to healthy male and female subjects.

Up to 6 dose levels will be evaluated. This study will have up to 10 cohorts and up to a total of approximately 76 subjects with either 4 or 8 healthy young subjects in Cohorts 1 through 9 or approximately 16 older subjects in Cohort 10. The starting dose of PB2452 will be 100 mg and the planned doses for subsequent cohorts are 300, 1000, 3000, 9000, and 18000 mg.

Conditions

  • Healthy

Interventions

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 MEDI2452 (PB2452) or Placebo

DRUG

Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment

Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo and Ticagerlor 180 mg 24 hours following MEDI2452 (PB2452) or Placebo

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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2018-09-18
Completion
2018-09-18
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 NCT03492385 on ClinicalTrials.gov