Status:
COMPLETED
Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers
Lead Sponsor:
Selecta Biosciences, Inc.
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068. Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and smoker volunteers. The resu...
Eligibility Criteria
Inclusion
- Primary
- Healthy Smokers
- Healthy non-smokers
- Written informed consent
- Primary
Exclusion
- Prior exposure to nicotine vaccines
- Female subjects of childbearing potential
- Current use of immunosuppressive agents
- History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection)
- Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01478893
Start Date
November 1 2011
End Date
March 1 2013
Last Update
January 7 2016
Active Locations (1)
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1
SGS LSS Clinical Pharmacology Unit
Antwerp, Belgium