FRTX-02 Capsule for Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Syneos Health Quebec, Montréal, Canada
Dermatitis+3 More
FRTX-02 Capsule - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

FRTX-02 is an orally-available, potent and selective DYRK1A inhibitor.

Eligible Conditions

  • Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Dermatitis

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2)

Day 43
The number of participants with treatment-emergent adverse events.

Trial Safety

Safety Progress

1 of 3

Other trials for Dermatitis

Trial Design

6 Treatment Groups

Part 1B Multiple Ascending Dose (MAD) - Active
1 of 6
Part 1A Single Ascending Dose (SAD) - Active
1 of 6
Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Active
1 of 6
Part 1B Multiple Ascending Dose (MAD) - Placebo
1 of 6
Part 1A Single Ascending Dose (SAD) - Placebo
1 of 6
Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo
1 of 6
Experimental Treatment
Non-Treatment Group

129 Total Participants · 6 Treatment Groups

Primary Treatment: FRTX-02 Capsule · Has Placebo Group · Phase 1

Part 1B Multiple Ascending Dose (MAD) - ActiveExperimental Group · 2 Interventions: FRTX-02 Capsule, BBI-02 Capsule · Intervention Types: Drug, Drug
Part 1A Single Ascending Dose (SAD) - ActiveExperimental Group · 2 Interventions: FRTX-02 Capsule, BBI-02 Capsule · Intervention Types: Drug, Drug
Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - ActiveExperimental Group · 2 Interventions: FRTX-02 Capsule, BBI-02 Capsule · Intervention Types: Drug, Drug
Part 1B Multiple Ascending Dose (MAD) - Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 1A Single Ascending Dose (SAD) - Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 8 (part a: sad); up to day 21 (part b mad); up to day 43 (part 2)
Closest Location: Syneos Health Quebec · Montréal, Canada
Photo of quebec 1Photo of quebec 2Photo of quebec 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Dermatitis
0 CompletedClinical Trials

Who is running the clinical trial?

Brickell Biotech, Inc.Lead Sponsor
11 Previous Clinical Trials
1,611 Total Patients Enrolled
2 Trials studying Dermatitis
67 Patients Enrolled for Dermatitis
Syneos HealthOTHER
154 Previous Clinical Trials
68,827 Total Patients Enrolled
Fresh Tracks Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
1,611 Total Patients Enrolled
2 Trials studying Dermatitis
67 Patients Enrolled for Dermatitis
Innovaderm Research Inc.OTHER
39 Previous Clinical Trials
2,432 Total Patients Enrolled
9 Trials studying Dermatitis
641 Patients Enrolled for Dermatitis

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 50 kilograms in weight (males) or 45 kilograms in weight (females).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.