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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05089409




Registration number
NCT05089409
Ethics application status
Date submitted
12/10/2021
Date registered
22/10/2021
Date last updated
11/10/2023

Titles & IDs
Public title
A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis
Scientific 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
Secondary ID [1] 0 0
ATB1651-101
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, 2 mg/mL
Treatment: Drugs - ATB1651, 5 mg/mL
Treatment: Drugs - ATB1651, 10 mg/mL
Treatment: Drugs - ATB1651, 20 mg/mL
Treatment: Drugs - ATB1651, 30 mg/mL
Other interventions - Placebo

Experimental: A (ATB1651, 2 mg/mL) - The planned ATB1651 dose level of 2 mg/mL.

Six participants are expected to be enrolled in each arm.

Experimental: B (ATB1651, 5 mg/mL) - The planned ATB1651 dose level of 5 mg/mL.

Six participants are expected to be enrolled in each arm.

Experimental: C (ATB1651, 10 mg/mL) - The planned ATB1651 dose level of 10 mg/mL.

Six participants are expected to be enrolled in each arm.

Experimental: D (ATB1651, 20 mg/mL) - The planned ATB1651 dose level of 20 mg/mL.

Six participants are expected to be enrolled in each arm.

Placebo comparator: E (ATB1651, 30 mg/mL) - The planned ATB1651 dose level of 30 mg/mL.

Six participants are expected to be enrolled in each arm.

Placebo comparator: F (placebo) - The participants will apply placebo for 28 days.

Six participants are expected to be enrolled in each arm.


Treatment: Drugs: ATB1651, 2 mg/mL
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

Treatment: Drugs: ATB1651, 5 mg/mL
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

Treatment: Drugs: ATB1651, 10 mg/mL
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

Treatment: Drugs: ATB1651, 20 mg/mL
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

Treatment: Drugs: ATB1651, 30 mg/mL
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

Other interventions: Placebo
The participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [1] 0 0
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Timepoint [1] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [2] 0 0
To assess the efficacy of ATB1651 in improving signs and symptoms of onychomycosis in participants with mild to moderate onychomycosis
Timepoint [2] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [4] 0 0
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal elimination rate constant
Timepoint [4] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [8] 0 0
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal half-life
Timepoint [8] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [9] 0 0
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent clearance
Timepoint [9] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [10] 0 0
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Apparent terminal volume of distribution
Timepoint [10] 0 0
From baseline to end of study treatment up to 56 days
Secondary outcome [11] 0 0
To assess whether there is systemic exposure following multiple doses of ATB1651 through pharmacokinetic analysis Parameters: Plasma ATB1651 trough concentrations (Ctrough) during multiple dosing
Timepoint [11] 0 0
From baseline to end of study treatment up to 56 days

Eligibility
Key inclusion criteria
1. Confirmation of onychomycosis by mycological staining and/or culture from affected great toenail(s).
2. 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.
3. The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is less than 3 mm.
4. Medically healthy with clinically insignificant Screening results (eg, laboratory profiles, medical history, ECGs, physical exam), as judged by the PI.
5. Negative urine drug screen and alcohol breath test at Screening and Day 1.
6. Body Mass Index (BMI) between 17.5 and 35.0, inclusive.
7. 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.
Minimum age
18 Years
Maximum age
65 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 COVID-19 test at Screening or any symptoms consistent with COVID-19 prior to initial dosing.
3. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
4. 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.
5. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
6. 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.
7. 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.

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 analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2023
Sample size
Target
Accrual to date
Final
30
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
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

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/study/NCT05089409
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05089409