Healthy adult participants Healthy participants
Conditions
Interventions
Transdermal formlation of SFG-02 or placebo is applied to abdomen skin single or repeated for 10 days
1) Part 1 (Japanese): single application once or twice
2) Part 2 (Japanese): repeated application
Sponsors
Tanaka Akira
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese or white male and female participants aged between 18 and 45 years at the time of consent. 2. Participants who agree to use contraception during a specified period. 3. Participants with a Body Mass Index (BMI) of at least 18.0 kg/m2 and less than 32.0 kg/m2. 4. Participants who are judged to be healthy by the principal (or sub-) investigator. 5. 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
Exclusion criteria: 1. Participants with clinically relevant symptoms, diseases, or pre-existing conditions. 2. Participants with extensive skin findings on the abdomen. 3. Participant who has used or will use prescription drugs, non-prescription drugs or products containing herbal medicines within a specified period 4. Participants whose normal weekly alcohol intake exceeds 150 g. 5. Habitual consumers of caffeine-containing beverages who are likely to experience symptoms if they stop. 6. Smokers or those who have smoked or used other nicotine-containing products within 6 months. 7. Participants who participated in a clinical trial and took a new active pharmacological ingredient within a specified period. 8. Participants who have undergone surgery within 4 weeks. 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety. tolerability and pharmacokinetics | — |
Contacts
Public ContactKazuo Watanabe
CTD inc.
Outcome results
None listed