Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357421
• Other study ID #: NMX-103
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2011
• Last updated: June 4, 2013
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2013
• Source: Transition Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Traumatic Brain Injury

Intervention

Drug:
• TT301
Single iv dose of TT301
• Placebo
Single iv dose of 0.9% sodium chloride for injection USP

Locations

Country	Name	City	State
United States	Duke Clinical Research Unit	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Transition Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine levels post LPS challenge		Measured up to 12h post-LPS	No