Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

Selecta Biosciences, Inc.72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Smoking Cessation

Interventions

SELA-070BIOLOGICAL

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 * 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.

Locations (1)

SGS LSS Clinical Pharmacology Unit

Antwerp, Belgium

Outcomes

Primary Outcomes

Safety and tolerability of multiple subcutaneous injections of SELA-070 as assessed by frequency of vaccine related adverse events, graded by severity

Time frame: 21 weeks

Secondary Outcomes

Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).

Time frame: 21 weeks

Data from ClinicalTrials.gov

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