Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

June 4, 2013 updated by: OPKO Health, Inc.

A Phase 1 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effects of a Single Intravenous Dose of TT301 on LPS-induced Changes in Blood Cytokine Levels in Healthy Male Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • 18 to 40 years, inclusive
  • 55 - 95 kg, inclusive

Exclusion Criteria:

  • Evidence of any clinically significant disease
  • History of cancer
  • History of syncope or severe vasovagal events
  • Antibiotic treatment within 60 days of Day 1
  • Surgical procedure within 60 days of Day 1
  • Hepatitis C, Hepatitis B
  • Tuberculosis
  • HIV
  • Requirement for medications (prescription/OTC) during the study
  • Donated > 250 mL blood within 30 days of Day 1
  • Donated > 750 mL blood within 60 days of Day 1
  • In a clinical trial of an immunosuppressive drug within 6 months of Day 1
  • Received any vaccination within 6 months of Day 1
  • Any clinically important allergy
  • Known allergy/sensitivity to lactose and/or polyethylene glycol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Normal saline
Drug: Placebo
Single iv dose of 0.9% sodium chloride for injection USP
Other Names:
  • 0.9% sodium chloride for injection USP
Experimental: TT301
Investigational drug TT301
Drug: TT301
Single iv dose of TT301
Other Names:
  • TT301 iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cytokine levels post LPS challenge
Time Frame: Measured up to 12h post-LPS
Measured up to 12h post-LPS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPKO Health, Inc.

Investigators

  • Study Director: Laura Agensky, BSc, MBA, Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Estimate)

June 6, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMX-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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