Overview
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.
Eligibility
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.
- Participants who have undergone surgery within 4 weeks.
- Pregnant or lactating women.