This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).
This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for people with moderate to severe atopic dermatitis. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies. Subjects will also be assessed for improvement in their atopic dermatitis. There will be a screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up with an end-of-study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Daily dose of ASN002 for 28 days
Placebo for ASN002 for 28 days
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Dermatology Research Associates
Los Angeles, California, United States
TCR Medical Corporation
San Diego, California, United States
Determine the maximum tolerated dose of ASN002
Analyze the number and type of adverse events reported.
Time frame: 43 days
Calculate the area under the plasma concentration versus time curve
A plot of the concentrations of ASN002 in blood plasma over time.
Time frame: 16 Days
Calculate the Pharmacokinetic maximum concentration
Maximum concentration of ASN002 achieved after dosing.
Time frame: 16 Days
Calculate the Pharmacokinetic Half-life
The time required for ASN002 concentration to decrease by 50%
Time frame: 16 Days
Change from baseline in the Investigator Global Assessment
determine overall severity of atopic dermatitis
Time frame: 28 days
Change from baseline in the subject-reported puritis (itch) score
Rating of puritis based degree, duration, direction, disability, and distribution
Time frame: 28 days
Change from baseline in EASI score
Measurement of area and severity of atopic dermatitis
Time frame: 28 days
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Olympian Clinical Research
Tampa, Florida, United States
Forward Clinical Trials, Inc.
Tampa, Florida, United States
Dermatology Specialists Research
Louisville, Kentucky, United States
Center for Clinical Studies, Ltd., LLP
Houston, Texas, United States
Progressive Clinical Research, P.A.
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Innovaderm Research
Montreal, Canada