Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

NCT03148925 — Phase 1, Completed, 72 participants, Selecta Biosciences, Inc.

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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

Registry	NCT03148925
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	72 (Actual)
Sponsor	Selecta Biosciences, Inc. (Industry)
Conditions	Smoking Cessation
Interventions	SELA-070, Saline (Biological)
Dates	start 2017-05-11, primary completion 2018-10-18, completion 2018-10-18, first posted 2017-05-11, last updated 2018-11-16
Locations	1 site in Belgium

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
SELA-070	Experimental	Biological: SELA-070
Saline	Placebo comparator	Biological: Saline

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

+Outcome measures

Primary outcomes

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 outcomes

Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). [21 weeks]

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
SGS LSS Clinical Pharmacology Unit	Antwerp	Belgium

+Investigators

Alexander Lucardie, MD, Principal investigator, SGS LSS Clinical Pharmacology Unit - Antwerpen

+Funding

NIH grants: 2017