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

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

Inclusion Criteria:

• Be male or female participants who are 18 to 75 years of age
• Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to the first study visit
• Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for used atopic dermatitis
• Have moderate-to-severe atopic dermatitis, at the first two study visits
• Use an emollient (except those containing urea) daily for at least 1 week prior to the first study visit and throughout the study

Exclusion Criteria:

• Have any uncontrolled current or recurrent concomitant illness (eg, hepatitis B surface antigen, hepatitis C virus, or other condition) that could affect the study drug, clinical or laboratory assessments, or could impact participant safety.
• Are using any medication (prescription or over-the-counter) that may interfere with the study product safety evaluations within 14-days prior to the second study visit.
• Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response.