Health ParticipantsPhase 1NCT07167914
A Study to Assess Safety, Tolerability and Pharmacokinetics of Transdermal SFG-02 in Healthy Participants
A Phase 1 study testing SFG-02 in people with Health Participants, run by Juro Sciences Inc. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Participants
- What is being tested?
- SFG-02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 9 Sep 2025to 27 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Transdermal Doses of SFG-02 in Japanese and White Healthy Adult Participants
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.
- Conditions
- Health Participants
- Being tested
- SFG-02, Placebo
- Keywords
- White Healthy Participants, Japanese Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFG-02Drug
Transdermal Formulation (SFG-02)
PlaceboDrug
Transdermal Formulation (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| (1) SFG-02 Single Transdermal Application | Experimental | Assign 8 Japanese Participants for SFG-02 or Placebo Application Receives: Drug: SFG-02; Drug: Placebo |
| (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) Receives: Drug: SFG-02; Drug: Placebo |
| (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) Receives: Drug: SFG-02; Drug: Placebo |
| (4) SFG-02 Single Transdermal Application (White) | Experimental | Assign 8 White Participants for SFG-02 or Placebo Application (single) Receives: Drug: SFG-02; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of Treatment-Emergent Adverse Events in Healthy Adult Subjects
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At designated timepoints (up to 7 days after the final application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start9 Sep 2025
- Primary completion27 Apr 2026
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juro Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167914
- Sponsor's protocol ID
- SFG-02-101
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Transdermal Doses of SFG-02 in Japanese and White Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07167914
- Acronym / sponsor ID
- SFG-02-101
- Conditions
- Health Participants
- Keywords
- White Healthy Participants, Japanese Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Juro Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (1) SFG-02 Single Transdermal Application | Experimental | Drug: SFG-02, Drug: PlaceboAssign 8 Japanese Participants for SFG-02 or Placebo Application |
| (2) SFG-02 (1st) Repeated Transdermal Application for 10 days | Experimental | Drug: SFG-02, Drug: PlaceboAssign 8 Japanese Participants for SFG-02 1st Dose or Placebo Application (10 days) |
| (3) SFG-02 (2nd) Repeated Transdermal Application for 10 days | Experimental | Drug: SFG-02, Drug: PlaceboAssign 8 Japanese Participants for SFG-02 2nd Dose or Placebo Application (10 days) |
| (4) SFG-02 Single Transdermal Application (White) | Experimental | Drug: SFG-02, Drug: PlaceboAssign 8 White Participants for SFG-02 or Placebo Application (single) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SFG-02Transdermal Formulation (SFG-02) | Drug | (1) SFG-02 Single Transdermal Application, (2) SFG-02 (1st) Repeated Transdermal Application for 10 days, (3) SFG-02 (2nd) Repeated Transdermal Application for 10 days, (4) SFG-02 Single Transdermal Application (White) |
| PlaceboTransdermal Formulation (Placebo) | Drug | (1) SFG-02 Single Transdermal Application, (2) SFG-02 (1st) Repeated Transdermal Application for 10 days, (3) SFG-02 (2nd) Repeated Transdermal Application for 10 days, (4) SFG-02 Single Transdermal Application (White) |
Primary outcome
Safety and Tolerability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SFG-02 in people with Health Participants, run by Juro Sciences Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: From the first application to the 14th day after the final application). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.