Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris

Detailed Description
-----------------
This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period

Official Title
-----------------
A Phase 1, Single-center, Open-label Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents With Moderate to Severe Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: SB204 4%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders Age 9-16 years, 11 months inclusive Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter Exclusion Criteria: Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis; Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc. Subjects who reside in a dwelling that relies on well water for a primary drinking source Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application Transgender subjects receiving hormone supplement (male to female or female to male) Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens Females who are pregnant, planning a pregnancy or breastfeeding Subjects previously treated with NVN1000 Gel / SB204

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB204 4%<br>Topically Once Daily (AM) | Drug: SB204 4%<br>* Topically Once Daily (AM)<br>* Other names: NVN1000;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration | Maximum plasma concentration of plasma hMAP3 on Day 21 | Day 21 | 
| AUC - area under the plasma concentration time curve for hMAP3 | AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma hMAP3 on Day 21 | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as measured by maximum concentration of nitrate | Cmax: maximum plasma concentration of plasma nitrate on Day 21 | Day 21 | 
| Pharmacokinetics (AUC) - area under the plasma concentration time curve for hMAP3 | AUC; area under the plasma concentration time curve from t=0 to the last measurable concentration for plasma nitrate on Day 21 | Day 21 | 
| Safety profile (Reported adverse events) | Reported adverse events | Day 21/End of Treatment | 
| Tolerability (Scores on tolerability assessment) | Scores on tolerability assessment during treatment | Day 21/End of treatment |