This is an ascending dose escalation study to test the safety, tolerability and preliminary efficacy of ASN008 TG in first-in-human subjects
This is a two part, randomized, blinded, vehicle-controlled study to determine a safe and tolerable dose of ASN008 TG. Part A will asses a single ascending dose of ASN008 TG in cohorts of healthy volunteers, while Part B will assess multiple ascending doses of TG, to be determined (TBD) based on Part A safety and tolerability, in patients with mild-to-moderate dermatitis. Results from Part A and B will characterize safety, tolerability and pharmacokinetics. Part B patients will be assessed for changes in pruritus based on a numerical rating scale (NRS) of pruritus at baseline and on Day 15.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
ASN008 TG
Placebo TG
Certified Research Associates
Cortland, New York, United States
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States
Progressive Clinical Research
San Antonio, Texas, United States
Spaulding Research Clinic, Inc
West Bend, Wisconsin, United States
Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B)
Analyze incidence of treatment-emergent adverse events (TEAE)
Time frame: Part A: 14 days; Part B: 22 days
Calculate area under the plasma concentration versus time curve (Part A and B)
A plot of the concentration of ASN008 in plasma over time
Time frame: 7 days and 16 days
Calculate the Pharmacokinetic Half-life (Part A and B)
Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%
Time frame: 7 days and 16 days
Calculate the Pharmacokinetic maximum concentration (Part A and B)
Maximum concentration of ASN008 achieved after dosing
Time frame: 7 days and 16 days
Change from baseline in pruritus NRS in AD subjects (Part B)
Numeric Rating Scale ranging from 0 to 10; 0 indicates no itching; 10 indicates worst possible itching; Rating of pruritis based degree, duration, direction, disability, and distribution
Time frame: 22 days
Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B)
Measurement of area and severity of atopic dermatitis based on composite score 0 to 72 encompassing degree of erythema, induration, excoriation and lichenification; each scored from 0 to 3 with 0 indicating none and 3 indicating severe
Time frame: 22 days
Change from baseline in Investigator Global Assessment Score in AD subjects (Part B)
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Innovaderm Recherches Inc
Montreal, Quebec, Canada
5 point morphological assessment of overall disease severity scored from 0 to 4 with 0 indicating clear (no inflammation) and 4 indicating severe (marked erythema)
Time frame: 22 Days