First in Human of Single and Multiple Doses of MOR106

Inclusion criteria

• Able and willing to give voluntary written informed consent

Single ascending dose (SAD)

• Negative urine drug screen
• Male between 18-50 years of age
• A body mass index (BMI) between 18-30 kg/m², inclusive.
• Judged to be in good health

Multiple ascending dose (MAD)

• Male or female between 18-65 years of age
• A BMI between 18-30 kg/m²
• Diagnosis of Atopic Dermatitis (AD) for at least 6 months as per the Hanifin and Rajka Criteria
• EASI ≥ 16 at the screening and baseline visits
• IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits
• Greater than or equal to 10% body surface area (BSA) of AD involvement at screening
• Willingness to continue stable use of an additive free, basic, bland emollient twice daily for at least 7 days before the baseline visit
• Subject is a candidate for systemic therapy and is not responding adequately or has a contraindication to topical corticosteroids and/or topical calcineurin inhibitors (per Investigator's judgement)
• Absence of current active, latent or history of tuberculosis (TB) infection based on medical history and as determined by a negative QuantiFERON TB Gold test at screening
• Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
• Female subjects of childbearing potential must use a highly effective method contraception from 28 days prior to the first dose of study drug, during the study and for at least 24 weeks after the last dose

Exclusion criteria

• Known hypersensitivity to study drug ingredients.
• History of or a current immunosuppressive condition
• Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
• Any concurrent illness, condition, disability, or clinically significant abnormality
• Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.
• A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (GI), pulmonary, or metabolic disease.

MAD only

• Active (skin) infection requiring systemic antibiotics
• immunosuppressive/immunomodulating drugs or phototherapy 4 weeks prior to baseline
• Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline
• Treatment with biologics within 5 half-lives (if known) or 12 weeks prior to baseline visit
• history of immunosuppression
• Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit
• Regular daily use of oral nonsteroidal anti-inflammatory drugs (NSAIDs), except low-dose aspirin (≤200 mg/day) for cardioprotection, within 7 days prior to screening