First-in-human, Single Center, Combined SAD/MAD, Double-blind, Placebo-controlled, Half-side Comparison Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of 0.1%, 0.3% and 1% WOL071-007-containing Formulations in Atopic Dermatitis Patients
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.
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