NCT00472758

A Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose for MEDI-545

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose, Intravenously Administered MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

-To evaluate the safety and tolerability of a multiple doses of this drug in adult patients.

Detailed description

-The primary objective of the study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-545 in adult patients with chronic plaque psoriasis.

Conditions

• Chronic Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	MEDI 545	IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg
OTHER	Placebo	IV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-02-01
• Completion: 2008-03-01
• First posted: 2007-05-14
• Last updated: 2011-11-17

Locations

3 sites across 1 country: Canada