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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Health Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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(1) SFG-02 Single Transdermal Application

Assign 8 Japanese Participants for SFG-02 or Placebo Application

Group Type EXPERIMENTAL

SFG-02

Intervention Type DRUG

Transdermal Formulation (SFG-02)

Placebo

Intervention Type DRUG

Transdermal Formulation (Placebo)

(2) SFG-02 (1st) Repeated Transdermal Application for 10 days

Assign 8 Japanese Participants for SFG-02 1st Dose or Placebo Application (10 days)

Group Type EXPERIMENTAL

SFG-02

Intervention Type DRUG

Transdermal Formulation (SFG-02)

Placebo

Intervention Type DRUG

Transdermal Formulation (Placebo)

(3) SFG-02 (2nd) Repeated Transdermal Application for 10 days

Assign 8 Japanese Participants for SFG-02 2nd Dose or Placebo Application (10 days)

Group Type EXPERIMENTAL

SFG-02

Intervention Type DRUG

Transdermal Formulation (SFG-02)

Placebo

Intervention Type DRUG

Transdermal Formulation (Placebo)

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

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

Group Type EXPERIMENTAL

SFG-02

Intervention Type DRUG

Transdermal Formulation (SFG-02)

Placebo

Intervention Type DRUG

Transdermal Formulation (Placebo)

Interventions

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SFG-02

Transdermal Formulation (SFG-02)

Intervention Type DRUG

Placebo

Transdermal Formulation (Placebo)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes