NCT03210961

A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis

A PHASE 1, WITHIN COHORT, RANDOMIZED, DOUBLE BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06826647 IN HEALTHY SUBJECTS AND SUBJECTS WITH PLAQUE PSORIASIS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	PF-06826647 tablet	PF-06826647 tablet for oral administration
DRUG	PF-06826647 oral suspension	PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)
OTHER	Placebo oral solution/suspension	placebo oral solution for the single ascending dose, first cohort only
OTHER	Placebo tablet	Matching placebo tablet

Timeline

• Start date: 2017-07-14
• Primary completion: 2019-01-25
• Completion: 2019-01-25
• First posted: 2017-07-07
• Last updated: 2020-03-31
• Results posted: 2020-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study