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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

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment141

FDA Designations

No designations recorded

Clinical trial landscape

PF-06881894 by on-body injector · 1 trial · 1 indication

Phase 1 1
NCT05194579Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled SyringeHealthy Volunteers
COMPLETED141 Analytics
PHASE1COMPLETED
Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe
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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 to 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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Frequently asked questions about PF-06881894 by on-body injector

What is PF-06881894 by on-body injector used for?

PF-06881894 by on-body injector is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed pharmacokinetic comparability study evaluating the on-body injector relative to a prefilled syringe. The drug is not approved and remains under clinical investigation.

Who makes PF-06881894 by on-body injector?

Pfizer, Inc. (NYSE: PFE) is developing PF-06881894 by on-body injector. The company is conducting clinical trials to evaluate the drug's pharmacokinetic comparability when administered via an on-body injector compared to a prefilled syringe in healthy participants.

What phase is PF-06881894 by on-body injector in?

PF-06881894 by on-body injector is in Phase 1 clinical development. One Phase 1 study has been completed, involving 141 healthy volunteers in the United States. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is PF-06881894 by on-body injector in?

PF-06881894 by on-body injector has one completed clinical trial, NCT05194579, titled "Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe." This Phase 1 study enrolled 141 healthy volunteers in the United States and was a controlled, randomized trial.

Is PF-06881894 by on-body injector FDA approved?

PF-06881894 by on-body injector is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed study, NCT05194579, assessed pharmacokinetic comparability in healthy volunteers, but the drug has not received regulatory approval.