Immunogenicity of ND1.1 by Delivery Directly to the Ileum
NCT ID: NCT01698060
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2012-09-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Intestinal Delivery
ND1.1
ND1.1
Interventions
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ND1.1
Eligibility Criteria
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Inclusion Criteria
* Healthy, as established by medical history, physical exam, and laboratory assessments
* Has normal bowel movements
* Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge
Exclusion Criteria
* Exposure to any investigational drug or vaccine 8 weeks prior to study
* Has traveled to Asia within 8 weeks of enrollment
* Abnormal ECG findings
* History of irritable bowl or any other inflammatory gastrointestinal disorder
* Any individual with increased risk for bowl obstruction
* Radiation exposure above target values 50 mSv within the past 30 days or a cumulative dose above 150 mSv in the past 12 months
* History of substance abuse
* Subject unwilling to use an approved method of contraception during study and for 2 months after study
* Positive for HCV, HIV, or HBV
* Presence of an implantable device that is sensitive to radio frequencies (e.g. pacemakers)
* History of an autoimmune disorder, or an immunosuppressive disorder
* Stool sample with occult blood at baseline
* Any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator, is a contraindication to the compliance of the protocol or informed consent
18 Years
49 Years
MALE
Yes
Sponsors
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Vaxart
INDUSTRY
Responsible Party
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Principal Investigators
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David Liebowitz, MD, PhD
Role: STUDY_DIRECTOR
Vaxart, Inc.
Locations
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Scintipharma
Lexington, Kentucky, United States
Countries
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Other Identifiers
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VXA01-001subA
Identifier Type: -
Identifier Source: org_study_id