Back to results

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

Primary Purpose

Atopic Dermatitis Eczema

Status

Terminated

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

FRTX-02 Capsule

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis Eczema

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Syneos Health Quebec

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1A Single Ascending Dose (SAD) - Active

Part 1A Single Ascending Dose (SAD) - Placebo

Part 1B Multiple Ascending Dose (MAD) - Active

Part 1B Multiple Ascending Dose (MAD) - Placebo

Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Active

Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo

Arm Description

Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers.

Matching placebo will be administered to healthy volunteers.

Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers.

Matching placebo will be administered to healthy volunteers.

FRTX-02 Capsules will be administered daily for 28 days to subjects with atopic dermatitis.

Matching placebo will be administered daily for 28 days to healthy volunteers.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05382819

First Posted

April 4, 2022

Last Updated

August 22, 2023

Sponsor

Fresh Tracks Therapeutics, Inc.

Collaborators

Syneos Health, Innovaderm Research Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05382819

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

Business Decision

Study Start Date

May 16, 2022 (Actual)

Primary Completion Date

February 8, 2023 (Actual)

Study Completion Date

August 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fresh Tracks Therapeutics, Inc.

Collaborators

Syneos Health, Innovaderm Research Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis Eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1A Single Ascending Dose (SAD) - Active

Arm Type

Experimental

Arm Description

Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers.

Arm Title

Part 1A Single Ascending Dose (SAD) - Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo will be administered to healthy volunteers.

Arm Title

Part 1B Multiple Ascending Dose (MAD) - Active

Arm Type

Experimental

Arm Description

Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers.

Arm Title

Part 1B Multiple Ascending Dose (MAD) - Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo will be administered to healthy volunteers.

Arm Title

Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Active

Arm Type

Experimental

Arm Description

FRTX-02 Capsules will be administered daily for 28 days to subjects with atopic dermatitis.

Arm Title

Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo will be administered daily for 28 days to healthy volunteers.

Intervention Type

Drug

Intervention Name(s)

FRTX-02 Capsule

Intervention Description

DYRK-1A Inhibitor

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo

Primary Outcome Measure Information:

Title

The number of participants with treatment-emergent adverse events.

Description

Number of participants with adverse events, abnormal vital signs, abnormal ECG readings and abnormal laboratory test results.

Time Frame

Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Syneos Health Quebec

City

Montréal

State/Province

Quebec

ZIP/Postal Code

QC G1P 0A2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs