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PF-06881894 by prefilled syringe (PFS) for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 0.167, 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
Awards & highlights

Study Summary

This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in approximately 134 healthy adult participants. Participants will be randomized into 2 sequences of treatment as described in the following table of Intervention Groups and Duration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 0.167, 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 0.167, 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
area under the serum concentration-time profile from time 0 extrapolated to infinite time (AUCinf) of PF-06881894
area under the serum drug concentration time profile from time 0 to the last quantifiable concentration (AUClast) of PF-06881894
maximum serum concentration (Cmax) of PF-06881894
Secondary outcome measures
Number of participants that report Adverse Events
terminal serum elimination half life (t½) of PF-06881894
time for Cmax (Tmax) of PF-06881894

Trial Design

2Treatment groups
Experimental Treatment
Group I: PF-06881894 by prefilled syringe (PFS)Experimental Treatment1 Intervention
PF-06881894 given by prefilled syringe (PFS) as reference arm, 6 mg administered as a single SC injection
Group II: PF-06881894 by on-body injector (OBI)Experimental Treatment1 Intervention
PF-06881894 given by on-body injector (OBI) as test arm, 6 mg administered as a single SC injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06881894 by prefilled syringe
2022
Completed Phase 1
~150
PF-06881894 by on-body injector
2022
Completed Phase 1
~150

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,299 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,413 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe
2022. "Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05194579.
~45 spots leftby Apr 2025
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