Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers

Selecta Biosciences

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Biological: Saline; Biological: SEL-068

Study type: Interventional

Funder types: Industry

Identifiers

NCT01478893

SEL-068/101

2011-003272-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

SEL-068

Experimental group

Treatment:

Biological: SEL-068

Saline

Placebo Comparator group

Treatment:

Biological: Saline