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

NCT07167914 | Completed Phase 1

• 1 other identifier: SFG-02-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Participants

Keywords

White Healthy Participants; Japanese Healthy Participants

Outcome Measures

Primary Outcomes (5)

• Safety and Tolerability

  Incidence of Treatment-Emergent Adverse Events in Healthy Adult Subjects

  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

  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

  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

  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

  At designated timepoints (up to 7 days after the final application)

Study Arms (4)

(1) SFG-02 Single Transdermal Application

EXPERIMENTAL

Assign 8 Japanese Participants for SFG-02 or Placebo Application

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)

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)

Drug: SFG-02; Drug: Placebo

(4) SFG-02 Single Transdermal Application (White)

EXPERIMENTAL

Assign 8 White Participants for SFG-02 or Placebo Application (single)

Drug: SFG-02; Drug: Placebo

Interventions

SFG-02 DRUG

Transdermal Formulation (SFG-02)

(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)

Placebo DRUG

Transdermal Formulation (Placebo)

(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)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juro Sciences Inc.: lead

Study Sites (1)

Sumida Hospital

Tokyo, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 11, 2025
• Study Start: September 9, 2025
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)