Trial | NCT01478893  Report issue

Title

Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers
A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SEL-068 in Healthy Non-Smoker and Smoker Adults

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    82
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 resulting safety profile and anti-nicotine antibody levels will be evaluated.
Study Started
Nov 30
2011
Primary Completion
Jan 31
2013
Study Completion
Mar 31
2013
Last Update
Jan 07
2016
Estimate

Biological SEL-068

Sub-cutaneous injection, multiple dose

Biological Saline

Sub-cutaneous injection, multiple dose

SEL-068 Experimental

Saline Placebo Comparator

Criteria 

Primary Inclusion Criteria:

Healthy Smokers
Healthy non-smokers
Written informed consent

Primary Exclusion Criteria:

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.
No Results Posted