A Phase 1, Adaptive, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SYX-5219 in Healthy Volunteers and Participants with Atopic Dermatitis

The primary objective of this Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics of SYX-5219 through single ascending dose and multiple ascending dose protocols in healthy participants, as well as a selected dose in individuals with atopic dermatitis. This investigation is critical to establish the initial safety profile and metabolic characteristics of the compound in humans. The study scope includes 4: Safety, 6: Pharmacokinetic.

The study population consists of 22 patients diagnosed with atopic dermatitis. This cohort includes both male and female participants. The study population is classified as vulnerable and falls within the pediatric age category.

This Phase 1, multi-part, adaptive clinical trial is designed to evaluate the safety, tolerability, and pharmacokinetics of SYX-5219. The study involves both healthy participants and individuals diagnosed with atopic dermatitis. The methodology includes a single ascending dose (SAD) component, a multiple ascending dose (MAD) component, and the administration of a selected dose for participants with the specified medical condition. The research sequence involves a screening visit to determine eligibility, followed by the scheduled dosing and assessment periods. Participants will undergo subsequent visits to monitor physiological responses and drug concentrations before reaching the end-of-study visit. The overall duration of the study is estimated to conclude by August 2026. Early termination from the study may occur based on safety protocols or clinical criteria.

The assessment of efficacy in this study concerning atopic dermatitis is not specified.