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

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

Detailed Description
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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).

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: SB414 2%
* Drug: SB414 6%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB414 2%<br>SB414 2% topically twice daily | Drug: SB414 2%<br>* Twice daily<br>* Other names: NVN1000;|
| Experimental: SB414 6%<br>SB414 6% topically twice daily | Drug: SB414 6%<br>* Twice daily<br>* Other names: NVN1000;|
| Placebo Comparator: Vehicle Cream<br>Vehicle Cream topically twice daily | Drug: Vehicle<br>* Placebo comparator<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of hMAP3 | Peak plasma concentrations of hMAP3 after topical application of SB414 | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics of SB414 | Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue) | Day 15 | 
| Safety Profile (Reported Adverse Events) | Reported Adverse Events | Day 15 | 
| Investigator Assessment of Tolerability | Investigator assessment of overall degree of irritation | Baseline, Week 1 and Week 2 | 
| Subject Assessment of Tolerability | Subject-reported from 5 point tolerability scale overall presence and degree of itching and burning / stinging | Baseline, Week 1 and Week 2 | 
| Efficacy as assessed by EASI (Eczema area and severity index) score | EASI Score will be collected | Screening, Baseline and Week 2 | 
| Efficacy as assessed by Target Lesion Severity Score | Target Lesion Severity Score will be collected | Screening, Baseline, Week 1 and Week 2 | 
| Efficacy as assessed by Itch NRS | Itching due to AD as reported by subject on an 11 point numerical rating scale | Baseline, Week 1 and Week 2 |