A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)

Exclusion Criteria

• •1. Evidence or history of a clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
• •2. Healthy volunteers who have a clinically relevant history or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
• •3. Healthy volunteers who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
• •4. Female Healthy volunteers who are pregnant, trying to become pregnant or lactating or breastfeeding.
• •5. Healthy volunteers who have participated in any investigational drug or device clinical study within 3 months prior to first dosing on this study.
• •6. Healthy volunteers who have previously participated in a study with an investigational product or device involving the dosing of a biological targeted at any immune pathway within 1 year prior to Screening.
• •1. Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent dermatological conditions other than AD or HS), significant physical examination or laboratory findings that may interfere with study objectives, in the Investigator's opinion (eg, conditions or findings that may expose a patient to unacceptable risk by study participation, confound the evaluation of treatment response or adverse events, or otherwise interfere with a patient's ability to complete the study).
• •2. Has an active systemic or soft tissue infection, including known actively-infected AD or HS skin lesion.
• •3. Treatment with an investigational product within 30 days or 5 half-lives preceding the first dose of investigational product (whichever is longer).
• •4. Use of prescription or nonprescription drugs including topical corticosteroids, vitaminic and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
• •5. Blood donation (excluding plasma donations and platelet donations) of approximately ≥400 mL within 3 months or ≥200 mL within a month prior to dosing.
• •6. History of sensitivity to heparin or heparin-induced thrombocytopenia.
• •7. Unwilling or unable to comply with the protocol procedures and/or assessments.
• •8. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
• •9. Patients with HS: Fistula and Tunnel count of \>20 at baseline.
• •10. Patients with AD: Active herpes infection or history of eczema herpeticum.