A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Topically Once Daily (AM)
WCCT #1
Austin, Texas, United States
Pharmacokinetics of hMAP3 as measured by the maximum observed plasma concentration
Maximum plasma concentration of plasma hMAP3 on Day 21
Time frame: 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
Time frame: Day 21
Pharmacokinetics as measured by maximum concentration of nitrate
Cmax: maximum plasma concentration of plasma nitrate on Day 21
Time frame: 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
Time frame: Day 21
Safety profile (Reported adverse events)
Reported adverse events
Time frame: Day 21/End of Treatment
Tolerability (Scores on tolerability assessment)
Scores on tolerability assessment during treatment
Time frame: Day 21/End of treatment
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