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PF-06881894 by on-body injector

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Aug 12, 2024

PF-06881894 by on-body injector development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since Aug 2018

PF-06881894 by on-body injector target and mechanism

ModalitySmall molecule

Also known as on-body injector

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment141

FDA Designations

No designations recorded

PF-06881894 by on-body injector clinical trials

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
Healthy VolunteersUnlock trial analytics

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?

PF-06881894 by on-body injector is an investigational small molecule therapeutic candidate developed by Pfizer, Inc. (NYSE: PFE). It is designed to be administered using an on-body injector device. The drug candidate has been studied in a Phase 1 clinical trial, but its specific therapeutic indications have not been disclosed.

Who is developing PF-06881894 by on-body injector?

PF-06881894 by on-body injector is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the sponsor of the clinical program for this drug candidate.

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 trial has been completed, and no active trials are currently listed. The drug candidate remains investigational and has not been approved by the FDA for any indication.

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

PF-06881894 by on-body injector has been evaluated in one completed Phase 1 clinical trial, NCT05194579. The trial was a pharmacokinetic comparability study in healthy participants, comparing the on-body injector to a prefilled syringe. It enrolled 141 participants in the United States.

How is PF-06881894 by on-body injector administered?

PF-06881894 is administered using an on-body injector, a device designed to deliver the drug subcutaneously. A Phase 1 trial compared the pharmacokinetics of the on-body injector relative to a prefilled syringe in healthy volunteers, evaluating whether the two delivery methods are comparable.