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NaxRedy

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 3, 2022

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05264493Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) AutoinjectorPHASE1 COMPLETED 13 — — Oct 6, 2020Jan 8, 2021Mar 3, 20221 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma naloxone concentration (Cmax) of a single 5 mg IM autoinjector injection compared to a 2 mg IM injection
predose, 2.5, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 360, 480, and 1440 minutes after dose

Comparison of bioavailability

Area under the naloxone concentration versus time curve (AUC) from time zero to the last collection time (AUClast) of a single 5 mg IM autoinjector injection compared to a 2 mg IM injection
predose, 2.5, 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 360, 480, and 1440 minutes after dose

Comparison of bioavailability

Secondary Endpoints
AUC from time zero to 2.5 minutes (AUC0-2.5)
predose and 2.5 minutes after dose
AUC from time zero to 5 minutes (AUC0-5)
predose, 2.5 and 5 minutes after dose
AUC from time zero to 15 minutes (AUC0-15)
predose, 2.5, 5, 10 and 15 minutes after dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
naloxone 5 mg IM autoinjectorEXPERIMENTALparticipants will receive in random order, a single naloxone 5 mg IM autoinjector injection into the lateral thigh
naloxone 2 mg IMACTIVE_COMPARATORparticipants will receive in random order, a single naloxone 2 mg IM injection into the gluteus muscle
naloxone 2mg bolus IVACTIVE_COMPARATORparticipants will receive in random order, a single naloxone 2 mg bolus IV injection
Interventions
NameTypeDescription
NaxRedy ™DRUG5 mg (5 mg/0.5 mL) IM autoinjector injection into lateral thigh
Naloxone Hydrochloride Injection, USPDRUG2 mg IM (2mg/2 mL) injection into gluteal muscle
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age and Sex: 1. Healthy male and/or female participants of non-childbearing potential, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Refe...

Countries:United States
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