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Prototype

Phase 1

Dental Plaque | Small molecule | ENT |Pfizer, Inc.|Trials Updated: Jun 5, 2019

Prototype target and mechanism

ModalitySmall molecule

Also known as Prototype (AN0128 Toothpaste)

Success Probability

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Market & Valuation

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Trial Design

PLACEBO_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Prototype clinical trials

Prototype · 1 trial · 1 indication

Phase 1 1
NCT00762151A Study to Investigate the Anti-Plaque Effect of AN0128 ToothpasteDental Plaque
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
Dental PlaqueUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
Baseline (time zero), 24 hour time point
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Study Design & Arms

MaskingNONE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Negative ControlPLACEBO_COMPARATORRegular Toothpaste
Positive ControlACTIVE_COMPARATORStandard anti-plaque and anti-bacterial toothpaste.
PrototypeACTIVE_COMPARATORAN0128 Toothpaste

Interventions

NameTypeDescription
Negative Control (Regular Toothpaste)OTHERRegular Toothpaste
Positive Control (anti-plaque/anti-bacterial toothpaste)OTHERStandard anti-plaque and anti-bacterial toothpaste
Prototype (AN0128 Toothpaste)DRUGAN0128 Toothpaste
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be between ages 18 to 65 years inclusive * Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present * Must give written informed consent * Be in good general health * Must discontinue oral hygiene for 24-hours after initial appointment * No known histor...

Countries:United States
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Frequently asked questions about Prototype

What is Prototype used for?

Prototype is an investigational small molecule developed for dental plaque. It was studied as a toothpaste formulation in a Phase 1 trial in healthy adult volunteers. It is not an approved product and remains in clinical development for its intended use in dental plaque.

Who makes Prototype?

Prototype is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical research evaluating the anti-plaque effect of the AN0128 toothpaste formulation in healthy adult volunteers.

What phase is Prototype in?

Prototype is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program has not advanced beyond early-stage testing, and Prototype is investigational rather than an approved therapy.

What clinical trials is Prototype in?

Prototype has been evaluated in one completed Phase 1 trial, NCT00762151, titled A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste. The trial enrolled 18 healthy adult volunteers in the United States, used a placebo control, and was conducted in participants aged 18 years and older.

Is Prototype the same as AN0128 Toothpaste?

Yes. Prototype is also known as AN0128 Toothpaste, and the two names refer to the same investigational product. The completed Phase 1 study NCT00762151 was conducted under the AN0128 Toothpaste designation, evaluating its anti-plaque effect in healthy adult volunteers.