OnychomycosisPhase 2NCT06327295
A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis
A Phase 2 study testing ATB1651-102- Cohort 1, ATB1651-102- Cohort 2 and ATB1651-102- Cohort 3 in people with Onychomycosis, run by AmtixBio Co., Ltd. at 1 site in New Zealand.
Trial summary
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- ATB1651-102- Cohort 1, ATB1651-102- Cohort 2 and ATB1651-102- Cohort 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNew Zealand
- Study dates
- 1 Jul 2024to 30 Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of onychomycosis by positive mycological (KOH) staining and positive culture from affected great toenail(s).
- Appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s), as determined by visual inspection after the nail has been trimmed. If the percentage of infection is outside this range but is still considered appropriate for this study, based on the overall impression of the Principal Investigator (PI), participation can be considered in consultation with the Medical Monitor (MM). The visual inspection results of the appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s) will be reviewed by the Sponsor before enrollment.
- The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is < 2 mm.
- Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening.
- In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination or ECG at Screening and/or before the first administration of IP at the discretion of the PI or designee. Participants with mild stable disease may be considered eligible at the discretion of the PI or designee.
- Body mass index (BMI) between 17.5 and 35.0 kg/m2, inclusive, at Screening.
Who cannot join
- History of allergy to any of the excipients in ATB1651.
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening or Day 1.
- Underlying physical or psychological medical conditions that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.
- Unwilling to refrain from the use of nail cosmetics such as clear and/ or colored nail lacquers from the Screening visit until the end of the study.
- Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening.
- Diabetes mellitus requiring treatment other than diet and exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research Christchurch
Christchurch, 8011
Corey Sellwood, Dr, +64 800 862 278
Corey Sellwood, Dr
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis
Read the detailed description
This Phase 2, multicenter, randomized, double-blind, placebo-controlled study is designed to assess the efficacy, safety, and tolerability of ATB1651 when administered topically to the great (hallux) toenail of participants with mild to moderate onychomycosis who are otherwise healthy.
This study will enroll upto 120 participants in 3+1 (optional) sequential cohorts.
- Participants in Cohorts 1 to 3 will be randomized within each cohort to receive either ATB1651 3% or placebo at a ratio of 5:1.
- An optional cohort (Cohort 4) may enroll up to 30 participants who will be randomized to receive either ATB1651 5% or placebo at a ratio of 5:1.
Dosing will start with Cohort 1 followed at least 4 weeks later by Cohort 2. The decision to continue dosing in Cohort 2 beyond 12 weeks and/or to commence Cohort 3, at the planned dosage regimen or a modified dosage regimen, will be determined by the Safety Review Committee (SRC).
- Conditions
- Onychomycosis
- Being tested
- ATB1651-102- Cohort 1, ATB1651-102- Cohort 2, ATB1651-102- Cohort 3, ATB1651-102- Cohort 4, Placebo
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATB1651-102- Cohort 1Drug
Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 once daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.
ATB1651-102- Cohort 2Drug
Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 once daily to the affected great toenail for 20 weeks with a follow-up for 16 weeks.
ATB1651-102- Cohort 3Drug
Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 twice daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.
ATB1651-102- Cohort 4Drug
Dosage form- Topical solution; Dosage- 5% formulation The participants will apply the daily dose of 5% ATB1651 once daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.
PlaceboDrug
participants will receive matching placebo across cohorts 1-4 of the study.
| Study group | Role | What they receive |
|---|---|---|
| ATB1651-102 Cohort 1 | Experimental | The planned ATB1651 dose of 3% solution to each infected toenail once daily for 12 weeks (follow up for 24 weeks) Twenty-five participants are expected to enroll per cohort. Receives: Drug: ATB1651-102- Cohort 1 |
| ATB1651-102 Cohort 2 | Experimental | The planned ATB1651 dose of 3% solution to each infected toenail once daily for 20 weeks follow up for 16 weeks) Twenty-five participants are expected to enroll per cohort. Receives: Drug: ATB1651-102- Cohort 2 |
| ATB1651-102 Cohort 3 | Experimental | The planned ATB1651 dose of 3% solution to each infected toenail twice daily for 12weeks follow up for 24 weeks).
Twenty-five participants are expected to enroll per cohort. Receives: Drug: ATB1651-102- Cohort 3 |
| ATB1651-102 Cohort 4 | Experimental | The planned ATB1651 dose of 5% solution to each infected toenail once daily for 12weeks follow up for 24 weeks).
Twenty-five participants are expected to enroll per cohort. Receives: Drug: ATB1651-102- Cohort 4 |
| Placebo | Placebo comparator | Matching placebo to the IP per cohort.
Five participants are expected to be enrolled per cohort. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis.
Complete cure rate (defined as 100% clear nail surface area for the target toenail at Week 36 and negative mycological evaluation of the affected great toe after the last dosing).
Measured: From screening to end of study treatment up to 252 days
Secondary outcomes (10)
To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis.
Efficacy of ATB1651 assessed based on Mycological evaluation of the affected great toenail(s) where ATB1651 was applied.
Standardized high-resolution photographs will also be taken and provided to a central reader to confirm the measurements Fungal growth will be measured for the affected great toenail(s) by direct mycological examination using staining (KOH) and culture of the nail scrapings for Trichophyton rubrum, Trichophyton mentagrophytes, Candida albicans, and other fungal species.
Measured: From screening to end of study treatment up to 252 days
To assess and collect the percentage and severity of adverse events (AEs).
Adverse Events include changes pain, erythema and local irritation, and clinically significant results from physical examinations. AE will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA®) Version 22.0 or higher.
Measured: From screening to end of study treatment up to 252 days
Maximum plasma concentration (Cmax)
Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by CMAX of ATB1651
Measured: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Time to maximum plasma concentration (Tmax)
Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 through Tmax of ATB1651
Measured: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent terminal elimination rate constant (λz)
Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by Apparent terminal elimination rate constant (λz)
Measured: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Area under curve (AUC)
Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by AUC
Measured: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent terminal half-life (t 1/2)
Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by (t 1/2)
Measured: Cohort 1, 3 and 5- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent clearance (CL)
Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by apparent clearance (CL).
Measured: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent terminal volume of distribution (VD)
Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by VD
Measured: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Plasma ATB1651 trough concentrations (Ctrough)
Pharmacokinetic profile characterized by trough concentrations (Ctrough) of ATB1651
Measured: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AmtixBio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327295
- Sponsor's protocol ID
- ATB1651-102
- Status last verified
- Feb 2025
- First submitted
- 29 Feb 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the
- ClinicalTrials.gov ID
- NCT06327295
- Acronym / sponsor ID
- ATB1651-102
- Conditions
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AmtixBio Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 25 Mar 2024 (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.
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis
Detailed description
This Phase 2, multicenter, randomized, double-blind, placebo-controlled study is designed to assess the efficacy, safety, and tolerability of ATB1651 when administered topically to the great (hallux) toenail of participants with mild to moderate onychomycosis who are otherwise healthy.
This study will enroll upto 120 participants in 3+1 (optional) sequential cohorts.
- Participants in Cohorts 1 to 3 will be randomized within each cohort to receive either ATB1651 3% or placebo at a ratio of 5:1.
- An optional cohort (Cohort 4) may enroll up to 30 participants who will be randomized to receive either ATB1651 5% or placebo at a ratio of 5:1.
Dosing will start with Cohort 1 followed at least 4 weeks later by Cohort 2. The decision to continue dosing in Cohort 2 beyond 12 weeks and/or to commence Cohort 3, at the planned dosage regimen or a modified dosage regimen, will be determined by the Safety Review Committee (SRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ATB1651-102 Cohort 1 | Experimental | Drug: ATB1651-102- Cohort 1The planned ATB1651 dose of 3% solution to each infected toenail once daily for 12 weeks (follow up for 24 weeks) Twenty-five participants are expected to enroll per cohort. |
| ATB1651-102 Cohort 2 | Experimental | Drug: ATB1651-102- Cohort 2The planned ATB1651 dose of 3% solution to each infected toenail once daily for 20 weeks follow up for 16 weeks) Twenty-five participants are expected to enroll per cohort. |
| ATB1651-102 Cohort 3 | Experimental | Drug: ATB1651-102- Cohort 3The planned ATB1651 dose of 3% solution to each infected toenail twice daily for 12weeks follow up for 24 weeks). Twenty-five participants are expected to enroll per cohort. |
| ATB1651-102 Cohort 4 | Experimental | Drug: ATB1651-102- Cohort 4The planned ATB1651 dose of 5% solution to each infected toenail once daily for 12weeks follow up for 24 weeks). Twenty-five participants are expected to enroll per cohort. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo to the IP per cohort. Five participants are expected to be enrolled per cohort. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmation of onychomycosis by positive mycological (KOH) staining and positive culture from affected great toenail(s).
- Appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s), as determined by visual inspection after the nail has been trimmed. If the percentage of infection is outside this range but is still considered appropriate for this study, based on the overall impression of the Principal Investigator (PI), participation can be considered in consultation with the Medical Monitor (MM). The visual inspection results of the appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s) will be reviewed by the Sponsor before enrollment.
- The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is < 2 mm.
- Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening.
- In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination or ECG at Screening and/or before the first administration of IP at the discretion of the PI or designee. Participants with mild stable disease may be considered eligible at the discretion of the PI or designee.
Key exclusion criteria (6 listed)
- History of allergy to any of the excipients in ATB1651.
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening or Day 1.
- Underlying physical or psychological medical conditions that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.
- Unwilling to refrain from the use of nail cosmetics such as clear and/ or colored nail lacquers from the Screening visit until the end of the study.
- Use of any IP or investigational medical device within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening.
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 |
|---|---|---|
| ATB1651-102- Cohort 1Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 once daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks. | Drug | ATB1651-102 Cohort 1 |
| ATB1651-102- Cohort 2Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 once daily to the affected great toenail for 20 weeks with a follow-up for 16 weeks. | Drug | ATB1651-102 Cohort 2 |
| ATB1651-102- Cohort 3Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 twice daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks. | Drug | ATB1651-102 Cohort 3 |
| ATB1651-102- Cohort 4Dosage form- Topical solution; Dosage- 5% formulation The participants will apply the daily dose of 5% ATB1651 once daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks. | Drug | ATB1651-102 Cohort 4 |
| Placeboparticipants will receive matching placebo across cohorts 1-4 of the study. | Drug | Placebo |
Primary outcome
To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis.
Time frame: From screening to end of study treatment up to 252 days
Complete cure rate (defined as 100% clear nail surface area for the target toenail at Week 36 and negative mycological evaluation of the affected great toe after the last dosing).
10 secondary outcomes
To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis.
Time frame: From screening to end of study treatment up to 252 days
To assess and collect the percentage and severity of adverse events (AEs).
Time frame: From screening to end of study treatment up to 252 days
Maximum plasma concentration (Cmax)
Time frame: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Time to maximum plasma concentration (Tmax)
Time frame: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent terminal elimination rate constant (λz)
Time frame: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Area under curve (AUC)
Time frame: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent terminal half-life (t 1/2)
Time frame: Cohort 1, 3 and 5- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent clearance (CL)
Time frame: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Apparent terminal volume of distribution (VD)
Time frame: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Plasma ATB1651 trough concentrations (Ctrough)
Time frame: Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATB1651-102- Cohort 1, ATB1651-102- Cohort 2 and ATB1651-102- Cohort 3 in people with Onychomycosis, run by AmtixBio Co., Ltd. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. 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 New Zealand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason (Jong-Seung) Lee (31 5175 8215 ext. +82, jason_lee@amtixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis. (time frame: From screening to end of study treatment up to 252 days). 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 19 Feb 2025.