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

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

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

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis Eczema
• Intervention / Treatment: Drug: Placebo; Drug: FRTX-02 Capsule

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, QC G1P 0A2
      • Syneos Health Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Fresh Tracks Therapeutics, Inc.
• Collaborators: Syneos Health; Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: BBI-02-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No