NCT07336940

Study of ENV-294 in Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Escalation, and Food Effect Study of ENV-294 in Healthy Adult Participants With a Phase 1b Extension in Adults With Moderate-To-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Enveda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the safety and tolerability of ENV-294 in adults with moderate to severe atopic dermatitis. It may also learn about the changes ENV-294 may have on the severity of atopic dermatitis symptoms. The main questions it will answer are: * Is ENV-294 safe and well tolerated in adults with moderate to severe atopic dermatitis? * Is there an impact on the severity of atopic dermatitis symptoms when participants take ENV-294? Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study. Participants will: * Take drug ENV-294 once every day for 28 days * Visit the clinic weekly for 4 weeks for checkups and tests * Keep a diary of their symptoms and when they took their study drug ENV-294

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	ENV-294 Capsule	ENV-294 formulated as 200mg capsules for oral administration will be used for this study.

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-01-13
• Completion: 2026-01-13
• First posted: 2026-01-13
• Last updated: 2026-04-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study