Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers
Phase 1
Completed
- Conditions
- Smoking Cessation
- Interventions
- Biological: SEL-068Biological: Saline
- Registration Number
- NCT01478893
- Lead Sponsor
- Selecta Biosciences, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEL-068 SEL-068 - Saline Saline -
- Primary Outcome Measures
Name Time Method 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 36 weeks
- Secondary Outcome Measures
Name Time Method Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). 36 weeks
Trial Locations
- Locations (1)
SGS LSS Clinical Pharmacology Unit
🇧🇪Antwerpen, Belgium