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NIC7-001

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment277

FDA Designations

No designations recorded

Clinical trial landscape

NIC7-001 · 1 trial · 2 indications

Phase 1 1
NCT01672645A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.Smoking
COMPLETED277 Analytics
PHASE1COMPLETED
A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.
Smoking
NCT01672645277
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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 to 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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Frequently asked questions about NIC7-001

What is NIC7-001 used for?

NIC7-001 is an investigational monoclonal antibody being studied for smoking cessation. It is intended to help healthy adult smokers quit smoking, though it is still in clinical development and not yet approved for this use.

Who makes NIC7-001?

NIC7-001 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is NIC7-001 in?

NIC7-001 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and tolerability.

What clinical trials is NIC7-001 in?

NIC7-001 has one completed clinical trial, identified as NCT01672645. This Phase 1 study assessed the safety and tolerability of different doses of PF-05402536 and PF-06413367 in healthy adult smokers, enrolling 277 participants in Canada.

Is NIC7-001 the same as PF-05402536 or PF-06413367?

NIC7-001 is associated with the investigational compounds PF-05402536 and PF-06413367, which were evaluated in the clinical trial NCT01672645. The trial assessed the safety and tolerability of these doses in healthy adult smokers.