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DYRK1A inhibitor

FRTX-02 Capsule for 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)

Awards & highlights

Study Summary

This trial is testing a new drug that may help treat Alzheimer's disease.

Eligible Conditions

Atopic Dermatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 8 (part a: sad); up to day 21 (part b mad); up to day 43 (part 2)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Do I qualify?Apply below to find out

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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

172 Previous Clinical Trials

68,365 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to enroll in this research project?

"Candidates looking to enroll in this trial should have dermatitis and must be within the ages of 18-55. Currently, 129 people are being recruited for participation."

Answered by AI

Is there any availability for participants in this research?

"This clinical experiment is currently recruiting participants, as evidenced on its profile hosted by clinicaltrials.gov. The trial was initially advertised on May 16th 2022 and has been updated most recently on September 12th 2022."

Answered by AI

Is participation in this trial limited to those aged 55 and younger?

"This medical trial is restricted to patients 18-55 years of age. However, there are 101 trials for minors and 165 studies open to senior citizens."

Answered by AI

What safety protocols are in place for users of FRTX-02 Capsule?

"As this is a Phase 1 trial, there is limited evidence to confirm the safety and efficacy of FRTX-02 Capsule. Thus our team at Power assigned it a score of 1 on their scale from 1 to 3."

Answered by AI

How many participants is the research team recruiting for this experiment?

"Affirmative. According to the information available on clinicaltrials.gov, this research study is currently enrolling participants. It was first posted on May 16th 2022 and has since been updated as of September 12th 2022. A total of 129 people need to be recruited at 1 medical facility for this trial to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05382819.