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Completed

NCT Number: NCT01357421

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TT301

Drug

Single iv dose of TT301

Other names: TT301 iv

Placebo

Drug

Single iv dose of 0.9% sodium chloride for injection USP

Other names: 0.9% sodium chloride for injection USP

Primary outcomes

  1. Cytokine levels post LPS challenge

    Time frame: Measured up to 12h post-LPS

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 20, 2011
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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