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

Juro Sciences Inc.

Status and phase: Enrolling; Phase 1

Conditions: Health Participants

Treatments: Drug: Placebo; Drug: SFG-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT07167914

SFG-02-101

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 4 patient groups

(1) SFG-02 Single Transdermal Application

Experimental group

Description:

Assign 8 Japanese Participants for SFG-02 or Placebo Application

Treatment:

Drug: SFG-02

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: SFG-02

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: SFG-02

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: SFG-02

Drug: Placebo