Clinical trial NCT02739009 (phase 1, status: completed)
Conditions: healthy, dermatitis, atopic
ICD codes: Z76.3, Z76.2, L20.89, L20.9
Drugs: mor106 single ascending doses, intravenous, placebo single ascending doses, intravenous, mor106 multiple ascending doses, intravenous, placebo multiple intravenous administrations
SMILES: CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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