Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06327295




Registration number
NCT06327295
Ethics application status
Date submitted
29/02/2024
Date registered
25/03/2024
Date last updated
25/03/2024

Titles & IDs
Public title
A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis
Scientific title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the
Secondary ID [1] 0 0
ATB1651-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Onychomycosis 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATB1651-102- Cohort 1
Treatment: Drugs - ATB1651-102- Cohort 2
Treatment: Drugs - ATB1651-102- Cohort 3
Treatment: Drugs - ATB1651-102- Cohort 4
Treatment: Drugs - Placebo

Experimental: ATB1651-102 Cohort 1 - 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.

Experimental: ATB1651-102 Cohort 2 - 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.

Experimental: ATB1651-102 Cohort 3 - 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.

Experimental: ATB1651-102 Cohort 4 - 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.

Placebo Comparator: Placebo - Matching placebo to the IP per cohort.
Five participants are expected to be enrolled per cohort.


Treatment: Drugs: ATB1651-102- Cohort 1
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.

Treatment: Drugs: ATB1651-102- Cohort 2
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.

Treatment: Drugs: ATB1651-102- Cohort 3
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.

Treatment: Drugs: ATB1651-102- Cohort 4
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.

Treatment: Drugs: Placebo
participants will receive matching placebo across cohorts 1-4 of the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis.
Timepoint [1] 0 0
From screening to end of study treatment up to 252 days
Secondary outcome [1] 0 0
To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis.
Timepoint [1] 0 0
From screening to end of study treatment up to 252 days
Secondary outcome [2] 0 0
To assess and collect the percentage and severity of adverse events (AEs).
Timepoint [2] 0 0
From screening to end of study treatment up to 252 days
Secondary outcome [3] 0 0
Maximum plasma concentration (Cmax)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Time to maximum plasma concentration (Tmax)
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Apparent terminal elimination rate constant (?z)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Area under curve (AUC)
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Apparent terminal half-life (t 1/2)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Apparent clearance (CL)
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Apparent terminal volume of distribution (VD)
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Plasma ATB1651 trough concentrations (Ctrough)
Timepoint [10] 0 0
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

Eligibility
Key inclusion criteria
1. Confirmation of onychomycosis by positive mycological (KOH) staining and positive
culture from affected great toenail(s).

2. 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.

3. The combined thickness of the distal nail plate at the associated hyperkeratotic nail
bed is < 2 mm.

4. Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening.

5. 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.

6. Body mass index (BMI) between 17.5 and 35.0 kg/m2, inclusive, at Screening.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of allergy to any of the excipients in ATB1651.

2. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or
human immunodeficiency virus (HIV) antibody at Screening or Day 1.

3. 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.

4. 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.

5. 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.

6. Diabetes mellitus requiring treatment other than diet and exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AmtixBio Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in
participants with mild to moderate onychomycosis
Trial website
https://clinicaltrials.gov/ct2/show/NCT06327295
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jason (Jong-Seung) Lee
Address 0 0
Country 0 0
Phone 0 0
31 5175 8215
Fax 0 0
Email 0 0
jason_lee@amtixbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06327295