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DYRK1A inhibitor

A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis

Phase 1
Waitlist Available
Research Sponsored by Brickell Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 8 (part a: sad); up to day 21 (part b mad); up to day 43 (part 2)

Summary

This trial tests a new oral medicine called FRTX-02 on healthy people and those with atopic dermatitis. It aims to see if the medicine is safe and how it behaves in the body.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 8 (part a: sad); up to day 21 (part b mad); up to day 43 (part 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 8 (part a: sad); up to day 21 (part b mad); up to day 43 (part 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number of participants with treatment-emergent adverse events.

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - ActiveExperimental Treatment1 Intervention
FRTX-02 Capsules will be administered daily for 28 days to subjects with atopic dermatitis.
Group II: Part 1B Multiple Ascending Dose (MAD) - ActiveExperimental Treatment1 Intervention
Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers.
Group III: Part 1A Single Ascending Dose (SAD) - ActiveExperimental Treatment1 Intervention
Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers.
Group IV: Part 1B Multiple Ascending Dose (MAD) - PlaceboPlacebo Group1 Intervention
Matching placebo will be administered to healthy volunteers.
Group V: Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - PlaceboPlacebo Group1 Intervention
Matching placebo will be administered daily for 28 days to healthy volunteers.
Group VI: Part 1A Single Ascending Dose (SAD) - PlaceboPlacebo Group1 Intervention
Matching placebo will be administered to healthy volunteers.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Brickell Biotech, Inc.Lead Sponsor
11 Previous Clinical Trials
1,601 Total Patients Enrolled
Fresh Tracks Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
1,601 Total Patients Enrolled
Syneos HealthOTHER
176 Previous Clinical Trials
68,566 Total Patients Enrolled
Innovaderm Research Inc.OTHER
48 Previous Clinical Trials
3,131 Total Patients Enrolled
~25 spots leftby Dec 2025
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