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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1) SFG-02 Single Transdermal Application | Experimental | Assign 8 Japanese Participants for SFG-02 or Placebo Application |
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| (2) SFG-02 (1st) Repeated Transdermal Application for 10 days | Experimental | Assign 8 Japanese Participants for SFG-02 1st Dose or Placebo Application (10 days) |
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| (3) SFG-02 (2nd) Repeated Transdermal Application for 10 days | Experimental | Assign 8 Japanese Participants for SFG-02 2nd Dose or Placebo Application (10 days) |
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| (4) SFG-02 Single Transdermal Application (White) | Experimental | Assign 8 White Participants for SFG-02 or Placebo Application (single) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SFG-02 | Drug | Transdermal Formulation (SFG-02) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence of Treatment-Emergent Adverse Events in Healthy Adult Subjects | 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 | 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 | 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 | 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 | At designated timepoints (up to 7 days after the final application) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida Hospital | Tokyo | Japan |
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| Placebo | Drug | Transdermal Formulation (Placebo) |
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