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

Inclusion criteria

For healthy subjects and subjects with atopic dermatitis:

• Males and females without childbearing potential.
• Age between 18 and 55, inclusive.
• Body mass index between 18 and 32 kg/m2, inclusive.
• Healthy apart from atopic dermatitis for the subjects presenting the disease.

For subjects with atopic dermatitis only:

• History of atopic dermatitis for more than 6 months.
• Female subjects with childbearing potential and male subjects with female partners with childbearing potential using highly effective contraception from start of the trial and until a period after the last administered dose of trial drug.

Exclusion criteria

For healthy subjects and subjects with atopic dermatitis:

• Any significant disease detected prior to enrolment.
• Subjects who are still participating in a clinical trial or who have participated in a clinical trial within 3 months prior to enrolment or within 5 times of the half-life of the experimental therapy, whichever is longer.
• Skin diseases that may interfere with the diagnosis of atopic dermatitis or assessment of the treatment.
• Use of tanning beds or phototherapy within 6 weeks prior to enrolment.
• Subjects with atopic dermatitis requiring more than 3 bleach baths from 4 weeks prior to screening until end of trial.
• Blood pressure or pulse rate outside of the normal range.

For subjects with atopic dermatitis only:

• Initiation of treatment of atopic dermatitis with prescription emollients during the screening period.