Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Transition Therapeutics
ClinicalTrials.gov Identifier:
NCT01357421
First received: May 13, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Transition Therapeutics:

Primary Outcome Measures:
  • Cytokine levels post LPS challenge [ Time Frame: Measured up to 12h post-LPS ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Transition Therapeutics
ClinicalTrials.gov Identifier: NCT01357421     History of Changes
Other Study ID Numbers: NMX-103
Study First Received: May 13, 2011
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014