MedTrace Logo

A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients

NCT05729074 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-15

No results posted yet for this study

Summary

This study aims to evaluate the safety, tolerability and pharmacokinetic properties of IN-A002 Ointment in healthy adult male volunteers and mild to moderate atopic dermatitis patients

Conditions

  • Mild to Moderate Atopic Dermatitis

Interventions

DRUG

IN-A002 Ointment 0.3% or IN-A002 Placebo Ointment

Drug: IN-A002 Ointment 0.3%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

DRUG

IN-A002 Ointment 0.5% or IN-A002 Placebo Ointment

Drug: IN-A002 Ointment 0.5%, 10 g/1000 cm2, for 1 day Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2, for 1 day

DRUG

IN-A002 Ointment 1% or IN-A002 Placebo Ointment

Drug: IN-A002 Ointment 1%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

DRUG

IN-A002 Ointment 3% or IN-A002 Placebo Ointment

Drug: IN-A002 Ointment 3%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

DRUG

IN-A002 Ointment 5% or IN-A002 Placebo Ointment

Drug: IN-A002 Ointment 5%, 10 g/1000 cm2 Drug: IN-A002 Placebo Ointment, 10 g/1000 cm2

DRUG

IN-A002 Ointment 1%

Drug: IN-A002 Ointment 1%, 3 g/1000 cm2

DRUG

IN-A002 Ointment 3%

Drug: IN-A002 Ointment 3%, 3 g/1000 cm2

DRUG

Elidel Cream 1% (pimecrolimus)

Drug: Elidel Cream 1% (pimecrolimus), 3 g/1000 cm2

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Min-kyu Park, MD, PhD · Department of Clinical Pharmacology, Chungbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2023-02-25
Completion
2024-01-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05729074 on ClinicalTrials.gov