Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis Clinical Trial
Official title:
A 6-part First-in-human Study of LOU064 Consisting of a 4-part Randomized, Double-blind, Placebo-controlled SAD and MAD Study to Investigate the Safety and Tolerability in Healthy Volunteers, Subjects With Atopic Diathesis and Subjects With Atopic Dermatitis, an Open-label Food Effect Study and a Double-blind Formulation Effect Study in Healthy Volunteers
This is a 6-part first-in-human study in up to approximately 184 participants. Parts 1 to 5 is in health volunteers and part 6 is in subjects with atopic dermatitis. The purpose of this first-in-human study is to assess the safety and tolerability and pharmacokinetics (PK) of single and multiple doses of LOU064 both as once and twice daily oral administration in healthy volunteers and those with atopic diathesis or atopic dermatitis. This study will also explore the effect of food intake and different drug substance particle sizes on the in vivo disposition of LOU064 in healthy volunteers to guide dosing and formulation development for future clinical trials. The study is registered on CT.Gov with the initiation of part 6 in patients (FPFV in April 2019).
The study is composed of the following parts: Part 1 is a double-blind, placebo-controlled single ascending dose (SAD) escalation study of up to 10 cohorts (N = approximately 80) in healthy volunteers Part 2 is a double-blind, placebo-controlled multiple ascending dose (MAD) escalation study in up to 6 cohorts in healthy volunteers with asymptomatic atopic diathesis with a 12-day treatment period (daily dosing) and 4-day follow-up period (N = approximately 48) Part 3 is a single cohort, single dose, open-label crossover food effect study (N = approximately 12) in healthy volunteers Part 4 is a double-blind, placebo-controlled multiple dose study in up to 2 cohorts of healthy volunteers with asymptomatic atopic diathesis with a 12-day treatment period (twice daily dosing) and 4-day follow-up period (N = approximately 16) Part 5 is a double-blind, single dose, crossover formulation effect study (N = approximately 12) in healthy volunteers Part 6 is a double-blind, placebo-controlled multiple dose study in subjects with atopic dermatitis with a 4-week treatment period (twice daily dosing of LOU064) and 3-week follow-up period in approximately 16 subjects ;