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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2018-05-11

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.

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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).

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SB414 2%

SB414 2% topically twice daily

Group Type EXPERIMENTAL

SB414 2%

Intervention Type DRUG

Twice daily

SB414 6%

SB414 6% topically twice daily

Group Type EXPERIMENTAL

SB414 6%

Intervention Type DRUG

Twice daily

Vehicle Cream

Vehicle Cream topically twice daily

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Placebo comparator

Interventions

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SB414 2%

Twice daily

Intervention Type DRUG

SB414 6%

Twice daily

Intervention Type DRUG

Vehicle

Placebo comparator

Intervention Type DRUG

Other Intervention Names

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NVN1000 NVN1000 Placebo

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes