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Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TT301
Placebo
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Duke Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TT301

Placebo

Arm Description

Investigational drug TT301

Normal saline

Outcomes

Primary Outcome Measures

Cytokine levels post LPS challenge

Secondary Outcome Measures

Full Information

First Posted
May 13, 2011
Last Updated
June 4, 2013
Sponsor
OPKO Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01357421
Brief Title
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TT301
Arm Type
Experimental
Arm Description
Investigational drug TT301
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
TT301
Other Intervention Name(s)
TT301 iv
Intervention Description
Single iv dose of TT301
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% sodium chloride for injection USP
Intervention Description
Single iv dose of 0.9% sodium chloride for injection USP
Primary Outcome Measure Information:
Title
Cytokine levels post LPS challenge
Time Frame
Measured up to 12h post-LPS

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Agensky, BSc, MBA
Organizational Affiliation
Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Duke Clinical Research Unit
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

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