This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Novella Site# 242
Coral Gables, Florida, United States
Novella Site# 264
Sweetwater, Florida, United States
Novella Site# 247
Boise, Idaho, United States
Novella Site# 251
Indianapolis, Indiana, United States
Plasma concentrations of hMAP3
Peak plasma concentrations of hMAP3 after topical application of SB414
Time frame: Day 15
Pharmacodynamics of SB414
Change in relevant Pre and post dose tissue cytokine levels (mg/mg tissue)
Time frame: Day 15
Safety Profile (Reported Adverse Events)
Reported Adverse Events
Time frame: Day 15
Investigator Assessment of Tolerability
Investigator assessment of overall degree of irritation
Time frame: 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
Time frame: Baseline, Week 1 and Week 2
Efficacy as assessed by EASI (Eczema area and severity index) score
EASI Score will be collected
Time frame: Screening, Baseline and Week 2
Efficacy as assessed by Target Lesion Severity Score
Target Lesion Severity Score will be collected
Time frame: 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
Time frame: Baseline, Week 1 and Week 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novella Site# 201
Berlin, New Jersey, United States
Novella Site# 250
Portland, Oregon, United States
Novella Site# 265
Hazleton, Pennsylvania, United States
Novells Site# 263
Pflugerville, Texas, United States
Novella Site# 114
Norfolk, Virginia, United States