A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ATTO-3712 in Healthy Adult Volunteers and Patients With Atopic Dermatitis
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-3712 in healthy adults and patients with atopic dermatitis. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-3712? How long does ATTO-3712 stay in the body after dosing? Researchers will compare ATTO-3712 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-3712 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.
• Any sex or gender who is 18 to 65 years old, inclusive, at Screening.
• 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 participants of child-bearing potential.
• Any sex or gender who is 18 to 65 years old
• Body weight of 50 to 125 kg and BMI between 18.5 and 40 kg/m2
• Clinically confirmed diagnosis of active AD
• History of inadequate response to treatment with topical medications
• Baseline weekly mean of daily PP-NRS ≥ 4 at Day 1.
• EASI score of ≥ 16 at Screening and Day 1
• vIGA-AD score of ≥ 3 at Screening and Day 1
• ≥10% of body surface area (BSA) affected by AD at Screening and Day 1
• Use of topical bland emollient (moisturizer) at least once 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
• Negative pregnancy test for participants of childbearing potential