This study is a single-center, randomized, single-blind, placebo-controlled, multiple ascending dose study of SM04755 solution applied topically once daily for 14 days to intact skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of 80 cm\^2. Dosing cohorts will consist of 8 subjects who will be randomized 3:1 (SM04755:placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Research Site
Tempe, Arizona, United States
Incidence of adverse events (AEs)
Incidence and severity of AEs events during the treatment and observation periods of the study
Time frame: Day 28
Incidence of clinical laboratory abnormalities
Incidence and severity of clinical laboratory measurements that are outside the normal range
Time frame: Day 28
Change in vital signs: blood pressure
Change from baseline in blood pressure
Time frame: Baseline and Day 28
Change in vital signs: temperature
Change from baseline in temperature
Time frame: Baseline and Day 28
Change in vital signs: respiratory rate
Change from baseline in respiratory rate
Time frame: Baseline and Day 28
Change in vital signs: pulse rate
Change from baseline in pulse rate
Time frame: Baseline and Day 28
Change in electrocardiogram (ECG) parameters
Change from baseline in 12-lead ECG parameters
Time frame: Baseline and Day 28
Plasma pharmacokinetics (PK): Cmax
Maximum plasma concentration (Cmax) estimate for SM04755 following first dose
Time frame: Day 1
Plasma pharmacokinetics (PK):tmax
Time to Cmax estimate for SM04755 following first dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1
Plasma pharmacokinetics (PK): AUC
Area under the plasma concentration-time curve (AUC) estimate for SM04755 following first dose
Time frame: Day 1
Plasma pharmacokinetics (PK):half-life
Plasma terminal phase half-life estimate for SM04755 following first dose
Time frame: Day 1
Plasma pharmacokinetics (PK):Cmax
Maximum plasma concentration (Cmax) estimate for SM04755 following last dose
Time frame: Day 14
Plasma pharmacokinetics (PK):tmax
Time to Cmax estimate for SM04755 following last dose
Time frame: Day 14
Plasma pharmacokinetics (PK): AUC
AUC estimate for SM04755 following last dose
Time frame: Day 14
Plasma pharmacokinetics (PK):half-life
Plasma terminal phase half-life estimate for SM04755 following last dose
Time frame: Day 14
Change in skin score assessment: erythema
Change from baseline in erythema skin score assessment
Time frame: Baseline and Day 28
Change in skin score assessment: scaling
Change from baseline in scaling skin score assessment
Time frame: Baseline and Day 28
Change in skin score assessment: pruritus/itching
Change from baseline in pruritus/itching skin score assessment
Time frame: Baseline and Day 28
Change in skin score assessment: burning/stinging
Change from baseline in burning/stinging skin score assessment
Time frame: Baseline and Day 28
Incidence of AEs relative to exposure
Incidence and severity of AEs relative to measured plasma exposure to SM04755
Time frame: Day 28