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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05382819

Enrollment

Registered

2022-05-19

Start date

2022-05-16

Completion date

2023-08-11

Last updated

2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis Eczema

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.

Interventions

DRUGFRTX-02 Capsule

DYRK-1A Inhibitor

DRUGPlacebo

Matching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
The number of participants with treatment-emergent adverse events.	Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2)	Number of participants with adverse events, abnormal vital signs, abnormal ECG readings and abnormal laboratory test results.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026