NCT01478893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

November 18, 2011

Last Update Submit

January 5, 2016

Conditions

Smoking Cessation

Keywords

nicotine vaccinesmoking vaccinesmoking cessationSEL-068

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).

    36 weeks

Study Arms (2)

SEL-068

EXPERIMENTAL
Biological: SEL-068

Saline

PLACEBO COMPARATOR
Biological: Saline

Interventions

SEL-068BIOLOGICAL

Sub-cutaneous injection, multiple dose

SEL-068
SalineBIOLOGICAL

Sub-cutaneous injection, multiple dose

Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Smokers
  • Healthy non-smokers
  • Written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS LSS Clinical Pharmacology Unit

Antwerp, Belgium

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Eva Vets, MD

    SGS LSS Clinical Pharmacology Unit - Antwerpen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 23, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

BE(1)