NCT03148925

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2017

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

First Submitted

Initial submission to the registry

May 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2018

Completed
Last Updated

November 16, 2018

Status Verified

September 1, 2018

Enrollment Period

1.4 years

First QC Date

May 9, 2017

Last Update Submit

November 15, 2018

Conditions

Smoking Cessation

Keywords

nicotine vaccinesmoking vaccinesmoking cessationSELA-070

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).

    21 weeks

Study Arms (2)

SELA-070

EXPERIMENTAL
Biological: SELA-070

Saline

PLACEBO COMPARATOR
Biological: Saline

Interventions

SELA-070BIOLOGICAL

Sub-cutaneous injection, multiple dose

SELA-070
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
  • 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

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

  • Alexander Lucardie, 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

May 9, 2017

First Posted

May 11, 2017

Study Start

May 11, 2017

Primary Completion

October 18, 2018

Study Completion

October 18, 2018

Last Updated

November 16, 2018

Record last verified: 2018-09

Locations

BE(1)