NCT02303509

Study to Assess Safety, Tolerability, Pharmacokinetic & Pharmacodynamic Effect of UCB5857 in Healthy & Psoriatic Subject

A Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study Evaluating The Safety/Tolerability, Pharmacokinetic and Pharmacodynamic Effects of UCB5857 in Healthy and Mild-to-Moderate Psoriatic Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single doses of the drug. Part 2 of the study explores giving the drug every day for 14 days. The study uses healthy and psoriasis subjects.

Detailed description

This is a first-in-human (FIH), Phase 1, randomized, double-blind, placebo controlled, single center study designed to evaluate the safety/ tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of UCB5857 following oral administration of single ascending doses (SAD) in healthy subjects (Part 1) and multiple ascending doses (MAD) in healthy and mild-to-moderate psoriatic subjects (Part 2). The primary objective of this study is to investigate the safety and tolerability of UCB5857 when given as single oral doses in healthy subjects and as ascending multiple oral doses in healthy subjects and mild-to-moderate psoriatic subjects.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	UCB5857 Part 1	Active substance: UCB5857 Pharmaceutical form: Capsule Concentration: 1 mg, 5 mg, 10 mg or 15 mg Route of administration: Oral
DRUG	UCB5857 Part 2	Active substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 8 mg, 15 mg Route of administration: Oral
OTHER	Placebo	Active substance: Placebo Pharmaceutical form: Capsule Concentration: Avicel PH 102, 50 mg Route of administration: Oral

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-12-01
• Last updated: 2014-12-01

Locations

1 site across 1 country: United Kingdom