NCT05383378

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

A Multi-center, Phase 1b, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Si-544 in Adults With Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: selectION Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	si-544	Subcutaneous injection in the abdomen
DRUG	Placebo	Subcutaneous injection in the abdomen

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2022-05-20
• Last updated: 2023-11-13

Locations

5 sites across 1 country: Germany