Phase 1 Study of BxC-I17e Injection for Safety and Tolerability in Adults with Moderate to Severe Atopic Dermatitis

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effects of a drug called BxC-I17e in adults with moderate to severe atopic dermatitis AD. This Phase 1 study aims to understand how patients respond to single and multiple doses of this treatment given by injection under the skin. The study focuses on patients who have had moderate to severe AD for at least one year and have not responded well to certain topical treatments. Participants will receive either a single or multiple subcutaneous injections of BxC-I17e at different dose levels 25, 50, or 100 micrograms or matching placebo injections. The single dose is given on Day 1, while the multiple doses occur on Days 1, 15, 29, and 43. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment period. Throughout the study, participants will have regular visits for safety checks, including monitoring for side effects, vital signs, lab tests, and heart function. Researchers will also assess skin condition improvements using various measures such as the Investigators Global Assessment, Body Surface Area affected, Eczema Area and Severity Index, and quality of life questionnaires. All safety and efficacy data will be collected from baseline up to 26 weeks, with some skin improvement assessments done up to 8 or 14 weeks depending on dosing. Participants must commit to follow study procedures and apply stable emollients before starting the trial.

A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis