This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of a novel transdermal formulation of SFG-02 following single and repeated applications in Japanese and White healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Sumida Hospital
Tokyo, Japan
Safety and Tolerability
Incidence of Treatment-Emergent Adverse Events in Healthy Adult Subjects
Time frame: From the first application to the 14th day after the final application
Pharmacokinetics (PK): Maximum concentration (Cmax) of SFG-02
Blood samples will be collected at multiple timepoints to estimate Cmax of SFG-02
Time frame: At designated timepoints (up to 7 days after the final application)
PK: Area under the concentration versus time curve (AUC) of SFG-02
Blood samples will be collected at multiple timepoints to estimate Tmax of SFG-02
Time frame: At designated timepoints (up to 7 days after the final application)
PK: Time to maximum concentration (Tmax) of SFG-02
Blood samples will be collected at multiple timepoints to estimate Tmax of SFG-02
Time frame: At designated timepoints (up to 7 days after the final application)
PK: Time to decrease the concentration by half (T1/2) of SFG-02
Blood samples will be collected at multiple timepoints to estimate T1/2 of SFG-02
Time frame: At designated timepoints (up to 7 days after the final application)
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