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Completed

NCT Number: NCT07167914

A Study to Assess Safety, Tolerability and Pharmacokinetics of Transdermal SFG-02 in Healthy 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.

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Key information

Conditions

Health Participants

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sumida Hospital

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SFG-02

Drug

Transdermal Formulation (SFG-02)

Placebo

Drug

Transdermal Formulation (Placebo)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Juro Sciences Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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