Health Participants
Conditions
Keywords
White Healthy Participants, Japanese Healthy Participants
Brief 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.
Interventions
DRUGSFG-02
Transdermal Formulation (SFG-02)
DRUGPlacebo
Transdermal Formulation (Placebo)
Sponsors
Juro Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
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 | Description |
|---|---|---|
| Safety and Tolerability | From the first application to the 14th day after the final application | Incidence of Treatment-Emergent Adverse Events in Healthy Adult Subjects |
| Pharmacokinetics (PK): Maximum concentration (Cmax) of SFG-02 | At designated timepoints (up to 7 days after the final application) | Blood samples will be collected at multiple timepoints to estimate Cmax of SFG-02 |
| PK: Area under the concentration versus time curve (AUC) of SFG-02 | At designated timepoints (up to 7 days after the final application) | Blood samples will be collected at multiple timepoints to estimate Tmax of SFG-02 |
| PK: Time to maximum concentration (Tmax) of SFG-02 | At designated timepoints (up to 7 days after the final application) | Blood samples will be collected at multiple timepoints to estimate Tmax of SFG-02 |
| PK: Time to decrease the concentration by half (T1/2) of SFG-02 | At designated timepoints (up to 7 days after the final application) | Blood samples will be collected at multiple timepoints to estimate T1/2 of SFG-02 |
Countries
Japan
Outcome results
None listed