Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote

A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03218241

Enrollment

Registered

2017-07-14

Start date

2012-06-30

Completion date

2012-10-31

Last updated

2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteers

Brief summary

This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects.

Interventions

BIOLOGICALPRT064445

Intravenous

DRUGPlacebo

Intravenous to mimic PRT064445

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy men or women between the ages of 18 and 50 years old, inclusive * BMI 19-32 and weighs at least 60kgs

Exclusion criteria

* History or symptoms of bleeding problems or thrombotic conditions * Clinically significant medical history * Major surgery, severe trauma, or bone fracture within 3 months

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics assessments	Up to 28 days

Secondary

Measure	Time frame
Pharmacokinetics: Plasma levels of PRT064445	Up to 7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026