Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064
Status:
Completed
Trial end date:
2020-01-27
Target enrollment:
Participant gender:
Summary
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).