Safety, Tolerability, Pharmacokinetics and Efficacy of WOL071-007 in Atopic Dermatitis Patients
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
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.