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

NCT01478893 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2016-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Smoking Cessation

Interventions

BIOLOGICAL

SEL-068

Sub-cutaneous injection, multiple dose

BIOLOGICAL

Saline

Sub-cutaneous injection, multiple dose

Sponsors & Collaborators

  • Selecta Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Eva Vets, MD · SGS LSS Clinical Pharmacology Unit - Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-01-31
Completion
2013-03-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478893 on ClinicalTrials.gov