Atopic Dermatitis EczemaPhase 1NCT05382819
A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis
A Phase 1 study testing FRTX-02 Capsule in people with Atopic Dermatitis Eczema, run by Fresh Tracks Therapeutics, Inc. at 1 site in Canada.
Trial summary
FRTX-02 is an orally-available, potent and selective DYRK1A inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- FRTX-02 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2022to 11 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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 locations and contacts
1 site in 1 country.
About this study
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
FRTX-02 is an orally-available, potent and selective DYRK1A inhibitor.
Read the 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
- Being tested
- FRTX-02 Capsule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRTX-02 CapsuleDrug
DYRK-1A Inhibitor
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1A Single Ascending Dose (SAD) - Active | Experimental | Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers. Receives: Drug: FRTX-02 Capsule |
| Part 1A Single Ascending Dose (SAD) - Placebo | Placebo comparator | Matching placebo will be administered to healthy volunteers. Receives: Drug: Placebo |
| Part 1B Multiple Ascending Dose (MAD) - Active | Experimental | Increasing dose of FRTX-02 Capsules will be administered to healthy volunteers. Receives: Drug: FRTX-02 Capsule |
| Part 1B Multiple Ascending Dose (MAD) - Placebo | Placebo comparator | Matching placebo will be administered to healthy volunteers. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start16 May 2022
- Primary completion8 Feb 2023
- Study completion11 Aug 2023
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresh Tracks Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Innovaderm Research Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382819
- Sponsor's protocol ID
- BBI-02-101
- Status last verified
- Aug 2023
- First submitted
- 4 Apr 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05382819
- Acronym / sponsor ID
- BBI-02-101
- Conditions
- Atopic Dermatitis Eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Fresh Tracks Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Innovaderm Research Inc.
- Study start
- 16 May 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1A Single Ascending Dose (SAD) - Active | Experimental | Drug: FRTX-02 CapsuleIncreasing dose of FRTX-02 Capsules will be administered to healthy volunteers. |
| Part 1A Single Ascending Dose (SAD) - Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered to healthy volunteers. |
| Part 1B Multiple Ascending Dose (MAD) - Active | Experimental | Drug: FRTX-02 CapsuleIncreasing dose of FRTX-02 Capsules will be administered to healthy volunteers. |
| Part 1B Multiple Ascending Dose (MAD) - Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered to healthy volunteers. |
| Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Active | Experimental | Drug: FRTX-02 CapsuleFRTX-02 Capsules will be administered daily for 28 days to subjects with atopic dermatitis. |
| Part 2 Subjects with Moderate to Severe Atopic Dermatitis (AD) - Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered daily for 28 days to healthy volunteers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRTX-02 CapsuleDYRK-1A Inhibitor | Drug | 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 |
| PlaceboMatching Placebo | Drug | 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 |
Primary outcome
The number of participants with treatment-emergent adverse events.
Time frame: 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.
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FRTX-02 Capsule in people with Atopic Dermatitis Eczema, run by Fresh Tracks Therapeutics, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with treatment-emergent adverse events. (time frame: Up to Day 8 (Part A: SAD); up to Day 21 (Part B MAD); up to Day 43 (Part 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.