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

Study Overview
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Brief Summary
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FRTX-02 is an orally-available, potent and selective DYRK1A inhibitor.

Detailed Description
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This is a randomized, placebo controlled, double blind study in healthy subjects and subjects with atopic dermatitis that is designed to assess the safety and tolerability of FRTX-02 capsules at single and multiple ascending doses. Safety will be assessed through vital signs, ECG, adverse events and safety laboratory tests. Pharmacokinetic and pharmacodynamic information will also be collected.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Single and Multiple Ascending Doses of FRTX-02 in Healthy Subjects and Subjects With Atopic Dermatitis

Conditions
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Atopic Dermatitis Eczema

Intervention / Treatment
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* Drug: FRTX-02 Capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Selected Inclusion Criteria Part 1 (SAD/MAD) Healthy male or female 18-55 years of age, inclusive At least 50 kg in weight (males) and 45 kg in weight (females) BMI 18.5-30.0 kg/m2, inclusive Part 2 (Subjects with AD) Male or female with atopic dermatitis 18-65 years of age, inclusive BMI 18-40.0 kg/m2, inclusive Validated Investigator's Global Assessment (vIGA-AD) score of ≥ 3 (moderate) Body surface area (BSA) with AD involvement ≥ 10% History of inadequate response to treatment with topical medications (e.g., corticosteroids, calcineurin inhibitors, etc.) or subjects for whom topical treatments are otherwise medically inadvisable. Selected Exclusion Criteria Part 1 (SAD/MAD) Use of tobacco products within 3 months prior to drug administration History of alcohol abuse or drug abuse Positive urine drug screen, alcohol breath test, or urine cotinine test Participation in a clinical research study involving the administration of an investigational or marketed drug within 30 days prior to drug administration Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing. Part 2 (Subjects with AD) History of alcohol abuse or drug abuse Positive urine drug screen, alcohol breath test, or urine cotinine test Participation in a clinical research study involving the administration of an investigational or marketed drug within 12 weeks prior to drug administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1A Single Ascending Dose (SAD) - Active<br>Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers. | Drug: FRTX-02 Capsule<br>* DYRK-1A Inhibitor<br>|
| Placebo Comparator: Part 1A Single Ascending Dose (SAD) - Placebo<br>Matching placebo will be administered to healthy volunteers. | Drug: Placebo<br>* Matching Placebo<br>|
| Experimental: Part 1B Multiple Ascending Dose (MAD) - Active<br>Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers. | Drug: FRTX-02 Capsule<br>* DYRK-1A Inhibitor<br>|
| Placebo Comparator: Part 1B Multiple Ascending Dose (MAD) - Placebo<br>Matching placebo will be administered to healthy volunteers. | Drug: Placebo<br>* Matching Placebo<br>|
| Experimental: Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Active<br>FRTX-02 Capsules will be administered daily for 28 days to subjects with atopic dermatitis. | Drug: FRTX-02 Capsule<br>* DYRK-1A Inhibitor<br>|
| Placebo Comparator: Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo<br>Matching placebo will be administered daily for 28 days to healthy volunteers. | Drug: Placebo<br>* Matching Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with treatment-emergent adverse events. | Number of participants with adverse events, abnormal vital signs, abnormal ECG readings and abnormal laboratory test results. | Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2) |