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

NCT ID: NCT05382819

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2023-08-11

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.

Conditions

Atopic Dermatitis Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1A Single Ascending Dose (SAD) - Active

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

Group Type: EXPERIMENTAL

FRTX-02 Capsule

Intervention Type: DRUG

DYRK-1A Inhibitor

Part 1A Single Ascending Dose (SAD) - Placebo

Matching placebo will be administered to healthy volunteers.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Part 1B Multiple Ascending Dose (MAD) - Active

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

Group Type: EXPERIMENTAL

FRTX-02 Capsule

Intervention Type: DRUG

DYRK-1A Inhibitor

Part 1B Multiple Ascending Dose (MAD) - Placebo

Matching placebo will be administered to healthy volunteers.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

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.

Group Type: EXPERIMENTAL

FRTX-02 Capsule

Intervention Type: DRUG

DYRK-1A Inhibitor

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo

Interventions

FRTX-02 Capsule

DYRK-1A Inhibitor

Intervention Type: DRUG

Placebo

Matching Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Innovaderm Research Inc.

OTHER

Sponsor Role: collaborator

Fresh Tracks Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Syneos Health Quebec

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

BBI-02-101

Identifier Type: -

Identifier Source: org_study_id