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

May 13, 2011
June 4, 2013
May 2011
June 2011   (final data collection date for primary outcome measure)
Cytokine levels post LPS challenge [ Time Frame: Measured up to 12h post-LPS ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01357421 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
  • Drug: TT301
    Single iv dose of TT301
    Other Name: TT301 iv
  • Drug: Placebo
    Single iv dose of 0.9% sodium chloride for injection USP
    Other Name: 0.9% sodium chloride for injection USP
  • Experimental: TT301
    Investigational drug TT301
    Intervention: Drug: TT301
  • Placebo Comparator: Placebo
    Normal saline
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01357421
NMX-103
No
Transition Therapeutics
Transition Therapeutics
Not Provided
Study Director: Laura Agensky, BSc, MBA Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.
Transition Therapeutics
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP