A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of AM1030-CREAM in patients with Atopic Dermatitis.

Official Title
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AM1030: A Phase I/II, Double-Blind, Placebo-Controlled, Single and Multiple Ascending (Topical) Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Patients (Male and Female) With Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: AM1030-CREAM or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and/or females of any ethnic origin between 18 and 65 years of age Body mass index between 18.0 and 35.0 kg/m2 Subjects with AD as defined by the Hanifen and Rajka criteria and with mild to severe disease activity (IGA 2-4) AD lesions amenable to cutaneous treatment located on the trunk and/or limbs Exclusion Criteria: Subjects with scars, moles, tattoos, sunburn or other blemishes in test areas Systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing Topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing Treatment with systemic antihistamines within 24 hours of the first dose administration Treatment with SSRIs within 2 weeks of the first dose administration Subjects who have received phototherapy within 4 weeks prior to dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAD 1<br>AM1030-CREAM | Drug: AM1030-CREAM or placebo<br> <br> |
| Experimental: SAD 2<br>AM1030-CREAM | Drug: AM1030-CREAM or placebo<br> <br> |
| Experimental: SAD 3<br>AM1030-CREAM | Drug: AM1030-CREAM or placebo<br> <br> |
| Experimental: MAD 1<br>AM1030-CREAM | Drug: AM1030-CREAM or placebo<br> <br> |
| Experimental: MAD 2<br>AM1030-CREAM | Drug: AM1030-CREAM or placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events as a measure of Safety | Day 1-15 | 
| Local Tolerability: Change in Erythema (Likert scale 0-4) | Change in Erythema (Likert scale 0-4) as a measure of Local Tolerability | Day 1-15 | 
| Local Tolerability: Change in Oedema (Likert scale 0-3) | Change in Oedema (Likert scale 0-3) as a measure of Local Tolerability | Day 1-15 | 
| Local Tolerability: Change in Burning (Likert scale 0-3) | Change in Burning (Likert scale 0-3) as a measure of Local Tolerability | Day 1-15 | 
| Local Tolerability: Change in Prutitus (VAS) | Change in Prutitus (VAS) as a measure of Local Tolerability | Day 1-15 | 
| Vital Signs | Change in blood pressure as a measure of Safety | Day 1-15 | 
| Vital Signs | Change in pulse rate as a measure of Safety | Day 1-15 | 
| Vital Signs | Change in body temperature as a measure of Safety | Day 1-15 | 
| ECG | Change in ECG as a measure of Safety | Day 1-15 | 
| Physical Examination | Any abnormal observations from Physical Examination as a measure of Safety | Day 1-15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Cmax, AUC, tmax, t1/2, Vss/F, CL/F | Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2, Vss/F, CL/F | Profil Day 1-15 | 
| Pruritus on a Visual Analog Scale | Pruritus (Visual Analog Scale 10 cm) as a measure of Efficacy | Day 1-15 | 
| Erythema on a Likert scale | Erythema (Likert Scale 0-4) as a measure of Efficacy | Day 1-15 | 
| Modified Eczema Area and Severity Index (mEASI) | mEASI (Composite score 0-64.8) as a measure of Efficay | Day 1-15 |