NCT03218241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2012

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

December 27, 2012

Last Update Submit

August 3, 2023

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamics assessments

    Up to 28 days

Secondary Outcomes (1)

  • Pharmacokinetics: Plasma levels of PRT064445

    Up to 7 days

Study Arms (5)

PRT0064445 Dose 1

EXPERIMENTAL

Dose 1 versus Placebo

Biological: PRT064445Drug: Placebo

PRT064445 Dose 2

EXPERIMENTAL

Dose 2 versus Placebo

Biological: PRT064445Drug: Placebo

PRT064445 Dose 3

EXPERIMENTAL

Dose 3 versus Placebo

Biological: PRT064445Drug: Placebo

PRT064445 Dose 4

EXPERIMENTAL

Dose 4 versus Placebo

Biological: PRT064445Drug: Placebo

PRT064445 Dose 5

EXPERIMENTAL

Dose 5 versus Placebo

Biological: PRT064445Drug: Placebo

Interventions

PRT064445BIOLOGICAL

Intravenous

PRT0064445 Dose 1PRT064445 Dose 2PRT064445 Dose 3PRT064445 Dose 4PRT064445 Dose 5
PlaceboDRUG

Intravenous to mimic PRT064445

Also known as: Placebo (for PRT064445)
PRT0064445 Dose 1PRT064445 Dose 2PRT064445 Dose 3PRT064445 Dose 4PRT064445 Dose 5

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Phoenix, Arizona, 85283, United States

Location

MeSH Terms

Interventions

PRT064445

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2012

First Posted

July 14, 2017

Study Start

June 1, 2012

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations

US(1)