Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SELA-070 in Healthy Adult Smokers

The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.

Primary Inclusion Criteria:

• Healthy Smokers
• Subjects must smoke a minimum of 10 but not more than 25 cigarettes per day for at least 3 months prior to enrollment
• 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.