Back to resultsA Study of ATB1651 in Adults With Mild to Moderate Onychomycosis
Primary Purpose
Onychomycosis
Status
Completed
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
ATB1651, 2 mg/mL
ATB1651, 5 mg/mL
ATB1651, 10 mg/mL
ATB1651, 20 mg/mL
ATB1651, 30 mg/mL
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- New Zealand Clinical Research Christchurch
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
A (ATB1651, 2 mg/mL)
B (ATB1651, 5 mg/mL)
C (ATB1651, 10 mg/mL)
D (ATB1651, 20 mg/mL)
E (ATB1651, 30 mg/mL)
F (placebo)
Arm Description
The planned ATB1651 dose level of 2 mg/mL. Six participants are expected to be enrolled in each arm.
The planned ATB1651 dose level of 5 mg/mL. Six participants are expected to be enrolled in each arm.
The planned ATB1651 dose level of 10 mg/mL. Six participants are expected to be enrolled in each arm.
The planned ATB1651 dose level of 20 mg/mL. Six participants are expected to be enrolled in each arm.
The planned ATB1651 dose level of 30 mg/mL. Six participants are expected to be enrolled in each arm.
The participants will apply placebo for 28 days. Six participants are expected to be enrolled in each arm.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal elimination rate constant
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
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
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
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal half-life
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent clearance
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal volume of distribution
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Plasma ATB1651 trough concentrations (Ctrough) during multiple dosing
Full Information
NCT ID
NCT05089409
First Posted
October 12, 2021
Last Updated
October 10, 2023
Sponsor
AmtixBio Co., Ltd.
Collaborators
Novotech (Australia) Pty Limited
1. Study Identification
Unique Protocol Identification Number
NCT05089409
Brief Title
A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
June 3, 2023 (Actual)
Study Completion Date
September 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AmtixBio Co., Ltd.
Collaborators
Novotech (Australia) Pty Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A (ATB1651, 2 mg/mL)
Arm Type
Experimental
Arm Description
The planned ATB1651 dose level of 2 mg/mL.
Six participants are expected to be enrolled in each arm.
Arm Title
B (ATB1651, 5 mg/mL)
Arm Type
Experimental
Arm Description
The planned ATB1651 dose level of 5 mg/mL.
Six participants are expected to be enrolled in each arm.
Arm Title
C (ATB1651, 10 mg/mL)
Arm Type
Experimental
Arm Description
The planned ATB1651 dose level of 10 mg/mL.
Six participants are expected to be enrolled in each arm.
Arm Title
D (ATB1651, 20 mg/mL)
Arm Type
Experimental
Arm Description
The planned ATB1651 dose level of 20 mg/mL.
Six participants are expected to be enrolled in each arm.
Arm Title
E (ATB1651, 30 mg/mL)
Arm Type
Placebo Comparator
Arm Description
The planned ATB1651 dose level of 30 mg/mL.
Six participants are expected to be enrolled in each arm.
Arm Title
F (placebo)
Arm Type
Placebo Comparator
Arm Description
The participants will apply placebo for 28 days.
Six participants are expected to be enrolled in each arm.
Intervention Type
Drug
Intervention Name(s)
ATB1651, 2 mg/mL
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ATB1651, 5 mg/mL
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ATB1651, 10 mg/mL
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ATB1651, 20 mg/mL
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ATB1651, 30 mg/mL
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days
Primary Outcome Measure Information:
Title
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
Description
Adverse Events will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA®) Version 22.0 or higher
Time Frame
From baseline to end of study treatment up to 56 days
Secondary Outcome Measure Information:
Title
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Description
Efficacy of ATB1651 assessed based on Mycological evaluation of the affected great toenail(s) where ATB1651 was applied
Time Frame
From baseline to end of study treatment up to 56 days
Title
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Description
Difference in the appearance of the affected great toenail(s) as determined by photographs throughout treatment and follow-up periods
Time Frame
From baseline to end of study treatment up to 56 days
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
New Zealand Clinical Research Christchurch
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis
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