OnychomycosisPhase 1NCT05089409
A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis
A Phase 1 study testing ATB1651, 2 mg/mL, ATB1651, 5 mg/mL and ATB1651, 10 mg/mL 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 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- ATB1651, 2 mg/mL, ATB1651, 5 mg/mL and ATB1651, 10 mg/mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNew Zealand
- Study dates
- 4 Mar 2022to 20 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of onychomycosis by mycological staining and/or culture from affected great toenail(s).
- Appearance of onychomycosis involving 20% to 70% 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 Investigator, participation can be considered in consultation with the Medical Monitor.
- The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is less than 3 mm.
- Medically healthy with clinically insignificant Screening results (eg, laboratory profiles, medical history, ECGs, physical exam), as judged by the PI.
- Negative urine drug screen and alcohol breath test at Screening and Day 1.
- Body Mass Index (BMI) between 17.5 and 35.0, inclusive.
- Agree to adhere to the current state and national advice regarding minimizing exposure to coronavirus disease of 2019 (COVID-19) from the Screening visit until the EOS visit.
Who cannot join
- History of allergy to any of the excipients in ATB1651.
- Positive COVID-19 test at Screening or any symptoms consistent with COVID-19 prior to initial dosing.
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
- Have any underlying physical or psychological medical conditions that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the study.
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- 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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
New Zealand Clinical Research Christchurch
Christchurch, 8011
About this study
Official title: A Phase 1, First in Human, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ATB1651 in Adults With Mild to Moderate Onychomycosis
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis.
Read the detailed description
Onychomycosis (also known as tinea unguium) is a contagious infection of toe nails by fungal organisms including dermatophytes, yeast, and molds.
This is phase 1, first in human, randomized, double-blind, placebo-controlled, MAD study designed to assess the safety, tolerability, and PK of ATB1651 when administered in participants with mild to moderate onychomycosis.
The study consists of 2 parts. In both parts, participants will receive multiple doses of ATB1651 applied to 1 affected great toenail and the remaining toenails (affected or not)
Part A: Participants will be enrolled into 1 of 3 cohorts and randomized to receive either ATB1651 or placebo at a ratio of 2:1.
Up to 2 additional cohorts may be added at the discretion of the Sponsor and Safety Monitoring Committee, if deemed necessary
Part B: Participants will be randomized within a single cohort to receive either ATB1651 or placebo at a ratio of 4:1
There will be 18 participants enrolled in part A, 30 participants in part B
- Conditions
- Onychomycosis
- Being tested
- ATB1651, 2 mg/mL, ATB1651, 5 mg/mL, ATB1651, 10 mg/mL, ATB1651, 20 mg/mL, ATB1651, 30 mg/mL
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATB1651, 2 mg/mLDrug
The participants will apply daily doses of ATB1651, 2 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
ATB1651, 5 mg/mLDrug
The participants will apply daily doses of ATB1651, 5 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
ATB1651, 10 mg/mLDrug
The participants will apply daily doses of ATB1651, 10 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
ATB1651, 20 mg/mLDrug
The participants will apply daily doses of ATB1651, 20 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
ATB1651, 30 mg/mLDrug
The participants will apply daily doses of ATB1651, 30 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days
PlaceboOther
The participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days
| Study group | Role | What they receive |
|---|---|---|
| A (ATB1651, 2 mg/mL) | Experimental | The planned ATB1651 dose level of 2 mg/mL.
Six participants are expected to be enrolled in each arm. Receives: Drug: ATB1651, 2 mg/mL |
| B (ATB1651, 5 mg/mL) | Experimental | The planned ATB1651 dose level of 5 mg/mL.
Six participants are expected to be enrolled in each arm. Receives: Drug: ATB1651, 5 mg/mL |
| C (ATB1651, 10 mg/mL) | Experimental | The planned ATB1651 dose level of 10 mg/mL.
Six participants are expected to be enrolled in each arm. Receives: Drug: ATB1651, 10 mg/mL |
| D (ATB1651, 20 mg/mL) | Experimental | The planned ATB1651 dose level of 20 mg/mL.
Six participants are expected to be enrolled in each arm. Receives: Drug: ATB1651, 20 mg/mL |
| E (ATB1651, 30 mg/mL) | Placebo comparator | The planned ATB1651 dose level of 30 mg/mL.
Six participants are expected to be enrolled in each arm. Receives: Drug: ATB1651, 30 mg/mL |
| F (placebo) | Placebo comparator | The participants will apply placebo for 28 days.
Six participants are expected to be enrolled in each arm. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of multiple ascending doses (MAD) of ATB1651 in participants with mild to moderate onychomycosis through the percentage and severity of adverse events including pain, erythema and local irritation
Adverse Events will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA®) Version 22.0 or higher
Measured: From baseline to end of study treatment up to 56 days
Secondary outcomes (11)
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis 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
Measured: From baseline to end of study treatment up to 56 days
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Difference in the appearance of the affected great toenail(s) as determined by photographs throughout treatment and follow-up periods
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Maximum plasma concentration and Time to maximum plasma concentration
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal elimination rate constant
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to 24 hours post dose
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to the last measurable concentration
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to infinity
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal half-life
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent clearance
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal volume of distribution
Measured: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Plasma ATB1651 trough concentrations (Ctrough) during multiple dosing
Measured: From baseline to end of study treatment up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start4 Mar 2022
- Primary completion3 Jun 2023
- Study completion20 Sep 2023
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmtixBio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089409
- Sponsor's protocol ID
- ATB1651-101
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First in Human, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ATB1651 in Adults With Mild to Moderate Onychomycosis
- ClinicalTrials.gov ID
- NCT05089409
- Acronym / sponsor ID
- ATB1651-101
- Conditions
- Onychomycosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AmtixBio Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 22 Oct 2021 (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
Onychomycosis (also known as tinea unguium) is a contagious infection of toe nails by fungal organisms including dermatophytes, yeast, and molds.
This is phase 1, first in human, randomized, double-blind, placebo-controlled, MAD study designed to assess the safety, tolerability, and PK of ATB1651 when administered in participants with mild to moderate onychomycosis.
The study consists of 2 parts. In both parts, participants will receive multiple doses of ATB1651 applied to 1 affected great toenail and the remaining toenails (affected or not)
Part A: Participants will be enrolled into 1 of 3 cohorts and randomized to receive either ATB1651 or placebo at a ratio of 2:1.
Up to 2 additional cohorts may be added at the discretion of the Sponsor and Safety Monitoring Committee, if deemed necessary
Part B: Participants will be randomized within a single cohort to receive either ATB1651 or placebo at a ratio of 4:1
There will be 18 participants enrolled in part A, 30 participants in part B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A (ATB1651, 2 mg/mL) | Experimental | Drug: ATB1651, 2 mg/mLThe planned ATB1651 dose level of 2 mg/mL. Six participants are expected to be enrolled in each arm. |
| B (ATB1651, 5 mg/mL) | Experimental | Drug: ATB1651, 5 mg/mLThe planned ATB1651 dose level of 5 mg/mL. Six participants are expected to be enrolled in each arm. |
| C (ATB1651, 10 mg/mL) | Experimental | Drug: ATB1651, 10 mg/mLThe planned ATB1651 dose level of 10 mg/mL. Six participants are expected to be enrolled in each arm. |
| D (ATB1651, 20 mg/mL) | Experimental | Drug: ATB1651, 20 mg/mLThe planned ATB1651 dose level of 20 mg/mL. Six participants are expected to be enrolled in each arm. |
| E (ATB1651, 30 mg/mL) | Placebo comparator | Drug: ATB1651, 30 mg/mLThe planned ATB1651 dose level of 30 mg/mL. Six participants are expected to be enrolled in each arm. |
| F (placebo) | Placebo comparator | Other: PlaceboThe participants will apply placebo for 28 days. Six participants are expected to be enrolled in each arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmation of onychomycosis by mycological staining and/or culture from affected great toenail(s).
- Appearance of onychomycosis involving 20% to 70% 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 Investigator, participation can be considered in consultation with the Medical Monitor.
- The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is less than 3 mm.
- Medically healthy with clinically insignificant Screening results (eg, laboratory profiles, medical history, ECGs, physical exam), as judged by the PI.
- Negative urine drug screen and alcohol breath test at Screening and Day 1.
Key exclusion criteria (7 listed)
- History of allergy to any of the excipients in ATB1651.
- Positive COVID-19 test at Screening or any symptoms consistent with COVID-19 prior to initial dosing.
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
- Have any underlying physical or psychological medical conditions that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the study.
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
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, 2 mg/mLThe participants will apply daily doses of ATB1651, 2 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days | Drug | A (ATB1651, 2 mg/mL) |
| ATB1651, 5 mg/mLThe participants will apply daily doses of ATB1651, 5 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days | Drug | B (ATB1651, 5 mg/mL) |
| ATB1651, 10 mg/mLThe participants will apply daily doses of ATB1651, 10 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days | Drug | C (ATB1651, 10 mg/mL) |
| ATB1651, 20 mg/mLThe participants will apply daily doses of ATB1651, 20 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days | Drug | D (ATB1651, 20 mg/mL) |
| ATB1651, 30 mg/mLThe participants will apply daily doses of ATB1651, 30 mg/mL to all 10 toenails including at least 1 affected great toenail for 28 days | Drug | E (ATB1651, 30 mg/mL) |
| PlaceboThe participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days | Other | F (placebo) |
Primary outcome
To assess the safety and tolerability of multiple ascending doses (MAD) of ATB1651 in participants with mild to moderate onychomycosis through the percentage and severity of adverse events including pain, erythema and local irritation
Time frame: From baseline to end of study treatment up to 56 days
Adverse Events will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA®) Version 22.0 or higher
11 secondary outcomes
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Time frame: From baseline to end of study treatment up to 56 days
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Maximum plasma concentration and Time to maximum plasma concentration
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal elimination rate constant
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to 24 hours post dose
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to the last measurable concentration
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Area under the drug concentration-time curve, from time zero to infinity
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal half-life
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent clearance
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal volume of distribution
Time frame: From baseline to end of study treatment up to 56 days
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Plasma ATB1651 trough concentrations (Ctrough) during multiple dosing
Time frame: From baseline to end of study treatment up to 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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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 ATB1651, 2 mg/mL, ATB1651, 5 mg/mL and ATB1651, 10 mg/mL 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 11 Oct 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 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the safety and tolerability of multiple ascending doses (MAD) of ATB1651 in participants with mild to moderate onychomycosis through the percentage and severity of adverse events including pain, erythema and local irritation (time frame: From baseline to end of study treatment up to 56 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 11 Oct 2023.