NCT01478893

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

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SEL-068 in Healthy Non-Smoker and Smoker Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Selecta Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	SEL-068	Sub-cutaneous injection, multiple dose
BIOLOGICAL	Saline	Sub-cutaneous injection, multiple dose

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2011-11-23
• Last updated: 2016-01-07

Locations

1 site across 1 country: Belgium