drugset / Trial / NCT03514511

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

NCT03514511

Phase 1 Completed 47 enrolled LEO Pharma
RandomizedSequentialDouble-blindTreatment

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).

Timeline

Start
2018-05-07
Primary completion
2021-03-02
Completion
2021-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject TEMTOKIBART Protein / enzyme biologic

Indications