drugset / Trial / NCT05383378

A First-In-Human Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis

NCT05383378 ↗

RandomizedSequentialTriple-blindTreatment

Summary

This is a multi-center, Phase 1b, double-blind, placebo-controlled, SAD and MAD, first-in-human study in subjects with mild to severe AD receiving si-544. The study consists of 2 parts, an SAD and an MAD part. In both parts, subjects will be treated in cohorts and will be randomized within each cohort to treatment with si-544 or placebo. Initially, 2 sentinel subjects will be treated (randomized to placebo or si-544) in each cohort.

Timeline

Start
2022-08-30
Primary completion
2023-11-01
Completion
2023-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject si-544 Unknown — Subcutaneous

Indications