Safety, Tolerability, Pharmacokinetics and Efficacy of WOL071-007 in Atopic Dermatitis Patients

Summary

Purpose of the study is the local tolerability and systemic safety of a novel k-opioid receptor agonist proven to inhibit inflammation and pruritus in preclinical model of dermatitis. Three concentrations of WOL071-007 and placebo will be applied to patients with AD in a first-in-human, single-center, combined single/multiple ascending dose (SAD/MAD), double-blind, placebo-controlled, half-side comparison (MAD part only) study. The IMP will be applied occlusively to lesional or non-lesional skin. In the SAD part 24 subjects will receive the IMP for 2 days. In the MAD part, 30 hospitalized subjects will receive the IMP for 6 days. Study objectives are the safety and tolerability as well as (MAD part only) the pharmacokinetics and efficacy of WOL071-007.

Timeline

Start

2014-03

Primary completion

2015-07

Completion

2015-07

Drugs

Indications