A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis

• Status: Completed
• Trial end date: 2018-05-11
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novan, Inc.
• Collaborator: Novella Clinical

Criteria

Inclusion Criteria:

• Male or female, 18 years of age and older, and in good general health;

• EASI score >1 and ≤21, involving ≥5% body surface area (BSA).

• Two target lesions at least 5 cm2 with a TLSS ≥5. Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp.

• Willing to not use any other products for AD during the study;

• Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit.

Exclusion Criteria:

• Concurrent or recent use of topical or systemic medications without a sufficient washout period;

• Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,

• Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;

• Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.