NCT05194579

Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, 2-WAY CROSSOVER STUDY ASSESSING PHARMACOKINETIC COMPARABILITY OF TWO PF-06881894 PRESENTATIONS, ON-BODY INJECTOR AND PREFILLED SYRINGE, IN HEALTHY PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PF-06881894 by on-body injector	PF-06881894 given by on-body injector (OBI), 6 mg administered as a single SC injection
COMBINATION_PRODUCT	PF-06881894 by prefilled syringe	PF-06881894 given by prefilled syringe (PFS), 6 mg administered as a single SC injection

Timeline

• Start date: 2022-02-10
• Primary completion: 2022-08-10
• Completion: 2022-08-10
• First posted: 2022-01-18
• Last updated: 2024-08-12
• Results posted: 2024-08-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study