Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

Selecta Biosciences

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Biological: SELA-070; Biological: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT03148925

2017-000534-65 (EudraCT Number)

SELA-070/101

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

SELA-070

Experimental group

Treatment:

Biological: SELA-070

Saline

Placebo Comparator group

Treatment:

Biological: Saline