A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
Status: | Completed |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/9/2018 |
Start Date: | November 13, 2017 |
End Date: | May 11, 2018 |
A Phase 1b Multi-Center, Double-Blind, Randomized Vehicle-Controlled Study Assessing the PK , Pharmacodynamics, Safety and Tolerability of SB414 in Subjects With Atopic Dermatitis
This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and
tolerability of SB414 in subjects with mild to moderate AD.
tolerability of SB414 in subjects with mild to moderate AD.
This is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be
conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD.
Subjects will be randomized to 2 active and 1 vehicle treatment arms. Subjects will apply the
study drug (SB414 or Vehicle) to affected areas twice daily for 2 weeks (14 days).
conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD.
Subjects will be randomized to 2 active and 1 vehicle treatment arms. Subjects will apply the
study drug (SB414 or Vehicle) to affected areas twice daily for 2 weeks (14 days).
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.
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