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NIC7-001

Phase 1

Smoking | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Jan 26, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment277
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01672645A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.PHASE1 COMPLETED 277 — — Jun 1, 2012Dec 1, 2015Jan 26, 20163 Canada
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Study Endpoints
Primary Endpoints
Frequency of solicited local reactions (erythema, induration, and pain) and severity of the local reactions as self-reported on electronic diaries (e-diaries) for 7 days following vaccination.
Within 7 days after dose
Frequency of solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and severity of solicited systemic events as self-reported on e-diaries for 7 days following vaccination.
Within 7 days after dose
Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment
Baseline up to Day 364
Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment
Baseline up to Day 364
Secondary Endpoints
Antibody titers against nicotine.
Up to Day 364
Avidity of antibodies against nicotine.
Up to Day 364
7-day point prevalence of smoking abstinence
Up to Day 364
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-05402536EXPERIMENTAL -
PF-06413367EXPERIMENTALIntramuscular, multiple dose
PlaceboPLACEBO_COMPARATORIntramuscular
Interventions
NameTypeDescription
NIC7-001BIOLOGICALIntramuscular, multiple dose
NIC7-003BIOLOGICALIntramuscular, multiple dose
SalineBIOLOGICALSaline (0.9% sodium chloride)
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Current cigarette smokers * Males or females of non-child bearing potential, who are between the minimum legal age for smoking (approximately 18 or 19 years, depending on local jurisdiction) and 55 years, inclusive, and who are motivated to stop smoking. * Subjects must have s...

Countries:Canada
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