First-in-human Study of DCY636 to Assess Safety and Effects in Healthy Adults and Adults With Moderate to Severe Atopic Dermatitis

What this Trial Is About

Researchers are studying DCY636, a new drug, to understand its safety, how it behaves in the body, and its immune effects in both healthy adults and adults with moderate to severe atopic dermatitis. This early phase 1 study aims to gather important information to support further testing of DCY636 in the future. The study is randomized, placebo-controlled, and blinded to ensure reliable results. The trial has two parts Part 1 involves healthy participants receiving single ascending doses of DCY636 or placebo across several dose levels. Part 2 includes participants with moderate to severe atopic dermatitis who receive multiple doses of DCY636 or placebo. Each group is carefully monitored to assess safety and drug behavior at different dose levels. Participants will be closely observed throughout the study, which lasts up to approximately 202 days for healthy participants and 301 days for those with atopic dermatitis. Researchers will monitor adverse events, drug levels, immune responses, and skin condition scores. Regular assessments include physical exams, lab tests, and questionnaires to track safety and how the drug affects the body over time.

A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic Dermatitis