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Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

This study has been completed.
Information provided by (Responsible Party):
Transition Therapeutics Identifier:
First received: May 13, 2011
Last updated: June 4, 2013
Last verified: June 2013
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

Condition Intervention Phase
Traumatic Brain Injury
Drug: TT301
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by Transition Therapeutics:

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

Enrollment: 18
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01357421

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

Responsible Party: Transition Therapeutics Identifier: NCT01357421     History of Changes
Other Study ID Numbers: NMX-103
Study First Received: May 13, 2011
Last Updated: June 4, 2013

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries processed this record on May 25, 2017