NCT03514511

Safety and Tolerability of LEO 138559 in Healthy Subjects and Subjects With Atopic Dermatitis

Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEO 138559 in Healthy Subjects and Subjects With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to investigate the safety and tolerability of LEO 138559 in healthy subjects and subjects with moderate to severe atopic dermatitis. The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics following administration of LEO 138559 to healthy subjects and subjects with moderate to severe atopic dermatitis. Healthy subjects will be exposed to 7 different dose regimens of LEO 138559 (one dose regimen per subject). Subjects with moderate to severe atopic dermatitis will be exposed to 2 different dose regimens of LEO 138559 (one dose regimen per subject).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	LEO 138559	LEO 138559 is a compound in development at LEO Pharma A/S
DRUG	LEO 138559 placebo	LEO 138559 placebo

Timeline

• Start date: 2018-05-07
• Primary completion: 2021-03-02
• Completion: 2021-03-02
• First posted: 2018-05-02
• Last updated: 2025-02-24

Locations

3 sites across 1 country: United Kingdom