Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus

Eligibility Criteria

• * Any sex or gender who is 18 to 65 years old
• * Body weight of 50 to 125 kg and body mass index (BMI) between 18.5 and 35 kg/m2
• * Considered in good general health based on medical history, physical exam, 12-lead ECG, screening clinical laboratory findings, and vital signs
• * Negative pregnancy test for subjects of child-bearing potential
• * Use of highly effective forms of birth control
• * Any clinically significant underlying illness.
• * History of malignancy within 5 years of Screening, except adequately treated basal carcinoma or in situ carcinoma of the cervix.
• * History of major surgery within 8 weeks prior to Day 1
• * History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
• * History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
• * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or is positive for HIV
• * Active or latent tuberculosis infection
• * Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
• * History of drug or alcohol abuse
• * Laboratory values outside of the normal range
• * Any clinically significant underlying illness
• * History of a clearly defined etiology for pruritus other than AD, including but not limited to urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
• * History of malignancy within 5 years of Screening
• * History of major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
• * History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
• * History of recurrent eczema herpeticum
• * History of known primary immunodeficiency, is considered immunocompromised, history of untreated latent tuberculosis infection, has been treated for active tuberculosis in the past year, or has been treated for a parasitic infection in the past 6 months
• * History of major depression
• * History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
• * Active HBV or HCV or is positive for HIV
• * Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
• * ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening
• * History of drug or alcohol abuse
• * Subject has applied topical corticosteroid in the 14 days preceding Day 1
• * Subject has used prohibited medications or therapies during the specified washout period before Day 1 (as defined in the protocol)
• * Laboratory values outside of the normal range
• * Primary dermatologic diagnosis associated with pruritic skin lesions at the time of screening
• * Regional neuropathic disease associated with pruritus
• * Severe renal failure requiring dialysis
• * Untreated cholestatic liver disease
• * Liver function tests (bilirubin, AST, ALT, alkaline phosphatase) \>2.5 times above the upper limit of normal
• * History of infectious dermatoses
• * Suspected diagnosis of somatoform pruritus
• * Suspected diagnosis of drug-induced pruritus
• * History of malignancy within 5 years of Screening
• * History of unexplained fevers, night sweats, or unintentional weight loss
• * Major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
• * History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
• * History of known primary immunodeficiency, is considered immunocompromised, untreated latent tuberculosis infection, has been treated for active tuberculosis in the past year, or has been treated for a parasitic infection in the past 6 months
• * History of attempted suicide
• * History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
• * Active HBV or HCV or is positive for HIV.
• * Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
• * ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening
• * History of drug or alcohol abuse
• * Use of prohibited medications as defined in the Protocol