A Study to Assess Safety, Tolerability and Pharmacokinetics of Transdermal SFG-02 in Healthy Part… (NCT07167914) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess Safety, Tolerability and Pharmacokinetics of Transdermal SFG-02 in Healthy Participants
Japan32 participantsStarted 2025-09-09
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy Japanese or white male and female participants aged between 18 and 45 years at the time of consent.
✓. Participants who agree to use contraception during a specified period.
✓. Participants with a Body Mass Index (BMI) of at least 18.0 kg/m2 and less than 32.0 kg/m2.
✓. Participants who are judged to be healthy by the principal (or sub-) investigator.
✓. Participants must understand the methods and compliance requirements of this study and must give his/her free and voluntary written consent to participate in this study.
Exclusion criteria
✕. Participants with clinically relevant symptoms, diseases, or pre-existing conditions.
✕. Participants with extensive skin findings on the abdomen.
✕. Participant who has used or will use prescription drugs, non-prescription drugs or products containing herbal medicines within a specified period
✕. Participants whose normal weekly alcohol intake exceeds 150 g.
✕. Habitual consumers of caffeine-containing beverages who are likely to experience symptoms if they stop.
✕. Smokers or those who have smoked or used other nicotine-containing products within 6 months.
✕. Participants who participated in a clinical trial and took a new active pharmacological ingredient within a specified period.
What they're measuring
1
Safety and Tolerability
Timeframe: From the first application to the 14th day after the final application
2
Pharmacokinetics (PK): Maximum concentration (Cmax) of SFG-02
Timeframe: At designated timepoints (up to 7 days after the final application)
3
PK: Area under the concentration versus time curve (AUC) of SFG-02
Timeframe: At designated timepoints (up to 7 days after the final application)
4
PK: Time to maximum concentration (Tmax) of SFG-02
Timeframe: At designated timepoints (up to 7 days after the final application)
5
PK: Time to decrease the concentration by half (T1/2) of SFG-02
Timeframe: At designated timepoints (up to 7 days after the final application)