NCT01483924

Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

A 12-week Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Sequential Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: ApoPharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.

Detailed description

A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1 B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days C) To evaluate the efficacy and pharmacodynamics of Apo805K1

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Apo805K1	Sequential parallel dose escalation.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2011-12-02
• Last updated: 2015-02-20
• Results posted: 2015-02-20

Locations

7 sites across 2 countries: United States, Canada