NCT05729074

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

A Randomized, Placebo/Active Controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1a/b Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

Part A: Phase 1a Study * Primary objective \- To evaluate the safety and tolerability after single/multiple dosing of topical IN-A002 Ointment in healthy adult male volunteers. * Secondary objective - To evaluate the pharmacokinetic (PK) profile after single/multiple dosing of topical IN-A002 Ointment in healthy adult male volunteers Part B: Phase 1b Study * Primary objective \- To evaluate the safety and tolerability after multiple dosing of topical IN-A002 Ointment in patients with mild to moderate atopic dermatitis. * Secondary objectives * To evaluate the PK profile after multiple dosing of topical IN-A002 Ointment in patients with mild to moderate atopic dermatitis. * To evaluate the efficacy after multiple dosing of topical IN-A002 Ointment in patients with mild to moderate atopic dermatitis.

Conditions

• Mild to Moderate Atopic Dermatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-13
• Primary completion: 2023-02-25
• Completion: 2024-01-31
• First posted: 2023-02-15
• Last updated: 2023-02-15