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NCT01357421 · ClinicalTrials.gov registry record · Phase 1

Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

A Phase 1 study of Traumatic Brain Injury, sponsored by OPKO Health.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT01357421 is a Phase 1 study of Traumatic Brain Injury that has completed, run by OPKO Health. The registered enrollment target is 18 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01357421, a Phase 1 study of Traumatic Brain Injury, has completed, sponsored by OPKO Health.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG TT301

Study Locations (1)

North Carolina

  • Duke Clinical Research Unit - Durham

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2011-05
Est. Completion 2011-06
Phase Phase 1

Sponsor

OPKO Health

32 total trials

What the Registry Record Tells You About NCT01357421

The ClinicalTrials.gov registry entry for NCT01357421 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (94% lower). The listed sponsor is OPKO Health, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01357421 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT01357421 about?

NCT01357421 is a clinical study titled "Effects of TT301 on Cytokine Levels Post Endotoxin Challenge". This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

What is the current status of trial NCT01357421?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-05. Estimated completion is 2011-06.

What conditions does trial NCT01357421 study?

This clinical trial studies the following conditions: Traumatic Brain Injury.

What interventions are being tested in trial NCT01357421?

The interventions under investigation include: Placebo (DRUG), TT301 (DRUG).

Who is sponsoring clinical trial NCT01357421?

This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01357421 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.