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

Fresh Tracks Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Atopic Dermatitis Eczema

Treatments: Drug: FRTX-02 Capsule; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05382819

BBI-02-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 6 patient groups, including a placebo group

Part 1A Single Ascending Dose (SAD) - Active

Experimental group

Description:

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

Treatment:

Drug: FRTX-02 Capsule

Part 1A Single Ascending Dose (SAD) - Placebo

Placebo Comparator group

Description:

Matching placebo will be administered to healthy volunteers.

Treatment:

Drug: Placebo

Part 1B Multiple Ascending Dose (MAD) - Active

Experimental group

Description:

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

Treatment:

Drug: FRTX-02 Capsule

Part 1B Multiple Ascending Dose (MAD) - Placebo

Placebo Comparator group

Description:

Matching placebo will be administered to healthy volunteers.

Treatment:

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: FRTX-02 Capsule

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo