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

Selecta Biosciences, Inc.82 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Smoking Cessation

Interventions

SEL-068BIOLOGICAL

Sub-cutaneous injection, multiple dose

SalineBIOLOGICAL

Sub-cutaneous injection, multiple dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

SGS LSS Clinical Pharmacology Unit

Antwerp, Belgium

Outcomes

Primary Outcomes

To assess the safety and tolerability of multiple subcutaneous injections of SEL-068 as assessed by frequency of vaccine related adverse events, graded by severity

Time frame: 36 weeks

Secondary Outcomes

Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).

Time frame: 36 weeks

Data from ClinicalTrials.gov

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