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PF-06881894 by on-body injector

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 12, 2024

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment141
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05194579Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled SyringePHASE1 COMPLETED 141 — — Feb 10, 2022Aug 10, 2022Aug 12, 20244 United States
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Study Endpoints
Primary Endpoints
Maximum Serum Concentration (Cmax) of PF-06881894
Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose

Cmax of PF-06881894 was defined as maximum serum concentration of PF-06881894. Observed directly from data.

Area Under the Serum Drug Concentration-time Profile From Time 0 to the Last Quantifiable Concentration (AUClast) of PF-06881894
Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose

AUClast of PF-06881894 was defined as area under the serum drug concentration-time profile from time 0 to the last quantifiable concentration. Linear/Log trapezoidal method was used.

Area Under the Serum Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06881894
Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose

AUCinf of PF-06881894 was defined as area under the serum concentration-time profile from time 0 extrapolated to infinite time.

Secondary Endpoints
Time for Cmax (Tmax) of PF-06881894
Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
Terminal Serum Elimination Half-life (t½) of PF-06881894
Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
Number of Participants With Treatment Emergent Adverse Events
From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-06881894 by on-body injector (OBI)OTHERPF-06881894 given by on-body injector (OBI) as test arm, 6 mg administered as a single SC injection
PF-06881894 by prefilled syringe (PFS)OTHERPF-06881894 given by prefilled syringe (PFS) as reference arm, 6 mg administered as a single SC injection
Interventions
NameTypeDescription
PF-06881894 by on-body injectorCOMBINATION_PRODUCTPF-06881894 given by on-body injector (OBI), 6 mg administered as a single SC injection
PF-06881894 by prefilled syringeCOMBINATION_PRODUCTPF-06881894 given by prefilled syringe (PFS), 6 mg administered as a single SC injection
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Healthy male and/or female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive. * Participants will include healthy individuals, with healthy being defined as no clinically relevant abnormalities identified by a detailed medical histo...

Countries:United States
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