A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis

NCT05089409 | Completed Phase 1 DMC

• 1 other identifier: ATB1651-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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

  From baseline to end of study treatment up to 56 days

Study Arms (6)

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.

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.

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.

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.

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.

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.

Other: Placebo

Interventions

ATB1651, 2 mg/mL DRUG

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

A (ATB1651, 2 mg/mL)

ATB1651, 5 mg/mL DRUG

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

B (ATB1651, 5 mg/mL)

ATB1651, 10 mg/mL DRUG

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

C (ATB1651, 10 mg/mL)

ATB1651, 20 mg/mL DRUG

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

D (ATB1651, 20 mg/mL)

ATB1651, 30 mg/mL DRUG

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

E (ATB1651, 30 mg/mL)

Placebo OTHER

The participants will apply placebo to all 10 toenails including at least 1 affected great toenail for 28 days

F (placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AmtixBio Co., Ltd.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

New Zealand Clinical Research Christchurch

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 22, 2021
• Study Start: March 4, 2022
• Primary Completion: June 3, 2023
• Study Completion: September 20, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

NZ (1)