Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients with Atopic Dermatitis

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 to 65

Critères de participation

Parts 1 \& 2 (Healthy Volunteers) Inclusion Criteria:

* Subject is an adult of any sex or gender who is 18 to 65 years old, inclusive, at Screening.
* Subject has a body weight of 50 to 125 kg, inclusive, and body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at Screening.
* Subject is considered in good general health in the opinion of the Investigator based on medical history, physical exam, 12-lead ECG, screening clinical laboratory findings, and vital signs at Screening and Day -1 or Day 1.
* Subjects of childbearing potential should have a negative pregnancy test at Screening and within 48 hours prior to the first dose.
* Subjects of childbearing potential agree to use highly effective forms of birth control.

Part 3 (Subjects with Atopic Dermatitis) Inclusion Criteria:

* Subject is an adult of any sex or gender who is 18 to 65 years old, inclusive, at Screening.
* Subject has a body weight of 50 to 125 kg, inclusive, and BMI between 18.5 and 40 kg/m2, inclusive, at Screening.
* Subject has a clinically confirmed diagnosis of active AD.
* Subject has at least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before Screening.
* Subject has a baseline weekly mean of daily PP-NRS ≥ 7 at Day 1.
* Subject has an EASI score of ≥ 7 at Screening and Day 1.
* Subject has a vIGA-AD score of ≥ 3 at Screening and Day 1.
* Subject has applied a stable dose of topical bland emollient (moisturizer) once or twice daily for at least 5 of the 7 days immediately before Day 1 and agrees to continue using that same emollient at the same frequency throughout the study.
* Subjects of childbearing potential should have a negative pregnancy test at Screening and within 48 hours prior to the first dose.
* Subjects of childbearing potential who are involved in any sexual intercourse that could lead to pregnancy agree to use highly effective forms of birth control.

Parts 1 \& 2 (Healthy Volunteers) Exclusion Criteria:

* 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
* Currently enrolled in another investigational device or drug study
* Laboratory values outside of the normal range.

Exclusion Criteria for Part 3 (Subjects with atopic dermatitis):

* 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
* 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, including, topical corticosteroids; other topicals such as calcineurin inhibitors, PDE-4 inhibitors, JAK inhibitors, emollients with active ingredients, topical retinoids, topical traditional Chinese medicines; oral antihistamines; biologics; immunosuppressants; other systemic medications such as gabapentinoids, tricyclic antidepressants, SSRI/SNRIs, opioid receptor blockers, oral retinoids, oral traditional Chinese medicines; and non-pharmacologic therapies including bleach baths, UV and other light therapies).
* Subject is currently enrolled in another investigational device or drug study.
* Laboratory values outside of the normal range