Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2018-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SELA-070

Group Type EXPERIMENTAL

SELA-070

Intervention Type BIOLOGICAL

Sub-cutaneous injection, multiple dose

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type BIOLOGICAL

Sub-cutaneous injection, multiple dose

Interventions

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SELA-070

Sub-cutaneous injection, multiple dose

Intervention Type BIOLOGICAL

Saline

Sub-cutaneous injection, multiple dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes