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

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.

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.