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

NCT05382819 | Terminated Phase 1

• 1 other identifier: BBI-02-101
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (6)

Part 1A Single Ascending Dose (SAD) - Active

EXPERIMENTAL

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

Drug: FRTX-02 Capsule

Part 1A Single Ascending Dose (SAD) - Placebo

PLACEBO COMPARATOR

Matching placebo will be administered to healthy volunteers.

Drug: Placebo

Part 1B Multiple Ascending Dose (MAD) - Active

EXPERIMENTAL

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

Drug: FRTX-02 Capsule

Part 1B Multiple Ascending Dose (MAD) - Placebo

PLACEBO COMPARATOR

Matching placebo will be administered to healthy volunteers.

Drug: Placebo

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

EXPERIMENTAL

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

Drug: FRTX-02 Capsule

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

FRTX-02 Capsule DRUG

DYRK-1A Inhibitor

Part 1A Single Ascending Dose (SAD) - Active; Part 1B Multiple Ascending Dose (MAD) - Active; Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Active

Placebo DRUG

Matching Placebo

Part 1A Single Ascending Dose (SAD) - Placebo; Part 1B Multiple Ascending Dose (MAD) - Placebo; Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Part 1 (SAD/MAD)
• Healthy male or female
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresh Tracks Therapeutics, Inc.: lead
• Syneos Health: collaborator
• Innovaderm Research Inc.: collaborator

Study Sites (1)

Syneos Health Quebec

Montreal, Quebec, QC G1P 0A2, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: May 19, 2022
• Study Start: May 16, 2022
• Primary Completion: February 8, 2023
• Study Completion: August 11, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)