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NCT05089409

A Study of ATB1651 in Adults With Mild to Moderate Onychomycosis

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
AmtixBio Co., Ltd.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Onychomycosis
Drug/Device/Intervention
ATB1651, 2 mg/mL
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AmtixBio Co., Ltd.
Timeline & enrollment
Phase
Phase 1
Start date
Nov 08, 2021
End date
Apr 30, 2023
Enrollment
60 participants
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

Summary

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

ICD-10 classifications
OnychogryphosisChromomycosis, unspecifiedOnycholysisActinomycosisBlastomycosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05089409
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05089409 through Pure Global AI's free database. This Phase 1 trial is sponsored by AmtixBio Co., Ltd. and is currently Not yet recruiting. The study focuses on Onychomycosis. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.