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

NCT03514511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-02-24

No results posted yet for this study

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

Interventions

DRUG

LEO 138559

LEO 138559 is a compound in development at LEO Pharma A/S

DRUG

LEO 138559 placebo

LEO 138559 placebo

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Study Director · LEO Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03514511 on ClinicalTrials.gov