Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

Smoking Cessation Clinical Trial

Official title:

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SELA-070 in Healthy Adult Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148925
• Other study ID #: SELA-070/101
• Secondary ID: 2017-000534-65
• Status: Completed
• Phase: Phase 1
• Start date: May 11, 2017
• Est. completion date: October 18, 2018

Study information

• Verified date: September 2018
• Source: Selecta Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 18, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Biological:
• SELA-070
Sub-cutaneous injection, multiple dose
• Saline
Sub-cutaneous injection, multiple dose

Locations

Country	Name	City	State
Belgium	SGS LSS Clinical Pharmacology Unit	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Selecta Biosciences, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of multiple subcutaneous injections of SELA-070 as assessed by frequency of vaccine related adverse events, graded by severity		21 weeks
Secondary	Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).		21 weeks