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Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

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ClinicalTrials.gov Identifier: NCT01357421
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
Transition Therapeutics

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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: TT301 Drug: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: TT301
Investigational drug TT301
Drug: TT301
Single iv dose of TT301
Other Name: TT301 iv
Placebo Comparator: Placebo
Normal saline
Drug: Placebo
Single iv dose of 0.9% sodium chloride for injection USP
Other Name: 0.9% sodium chloride for injection USP



Primary Outcome Measures :
  1. Cytokine levels post LPS challenge [ Time Frame: Measured up to 12h post-LPS ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357421


Locations
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Transition Therapeutics
Investigators
Study Director: Laura Agensky, BSc, MBA Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.

Responsible Party: Transition Therapeutics
ClinicalTrials.gov Identifier: NCT01357421     History of Changes
Other Study ID Numbers: NMX-103
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries