Study to Evaluate ASN008 Topical Gel (TG)
- Conditions
- PruritusDermatitis EczemaDermatitis, Atopic
- Interventions
- Registration Number
- NCT03798561
- Lead Sponsor
- Asana BioSciences
- Brief Summary
This is an ascending dose escalation study to test the safety, tolerability and preliminary efficacy of ASN008 TG in first-in-human subjects
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Part A - Healthy Volunteers:
- Written informed consent obtained prior to any required study-related procedure
- Healthy female or male subject aged 18 to 65
- Willing to use medically effective methods of birth control
- Females of reproductive potential must have a negative serum pregnancy test at screening and negative serum or urine pregnancy test prior to first study drug application on Day 1
- Non-smoker (no nicotine products for at least 6 months prior to screening)
- BMI ≥18.5 kg/m2 and ≤32.0 kg/m2 with minimum weight of 60 kg
Part B- Subjects with AD:
- Written informed consent obtained prior to any required study-related procedure
- Confirmed diagnosis of active atopic dermatitis (AD)
- History of AD for at least 6 months prior to Day 1 with an investigator global assessment ≥3 and body surface area covered with 1-10% AD
- Pruritus score (NRS)≥ 5 at screening and NRS ≥7 on Day 1
Both Part A and Part B:
- Pregnant or breast-feeding women
- Skin disease that may interfere with study assessments
- Febrile illness within 6 days prior to Day 1, history of cancer within 5 years of Day 1, major surgery within 8 weeks prior to Day1, known immunodeficiencies, positive for hepatitis B or C or HIV infection
- Significant medical/surgical history or condition or current physical/laboratory/ECG/ vitals signs abnormality that might compromise the subject
- Corrected QT duration ≥450 milliseconds or other significant ECG abnormality
- Received marketed or investigational biological agent within 12 weeks prior to Day 1 or JAK inhibitor or nonbiological product or device within 4 weeks of Day 1 or within 8 weeks of Day 1 if investigational product used or any drug/ substance that is a strong inhibitor or inducer of CYP3A4 or CYP2D6
- Suspected hypersensitivity/allergy to lidocaine
- Significant drug or alcohol abuse or mental illness in 2 years prior to Day 1
Part A Only- Healthy Volunteers:
-Used medications or skin emollients within 2 weeks prior to Day 1 unless approved by investigator and sponsor
Part B Only - Subjects with AD:
- Has infected atopic dermatitis
- Used dupilumab 12 weeks prior to Day 1
- Used doxepin, hydroxyzine or diphenhydramine, urea containing topical products within 1 week prior to Day 1
- Used systemic antibiotics or topical medicated treatment or other systemic treatments that could affect AD 2 weeks prior to Day 1
- Received any UV-B phototherapy, excimer laser treatment or psoralen-UV-A treatment within 4 weeks prior to Day 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 82 µg/cm2 ASN008 TG or Placebo Placebo TG PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2) 328 µg/cm2 ASN008 TG or Placebo ASN008 TG Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2) ASN008 TG TBD Cohort 1 or Placebo ASN008 TG Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3) ASN008 TG TBD Cohort 1 or Placebo Placebo TG Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3) ASN008 TG TBD Cohort 3 or Placebo ASN008 TG Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3) ASN008 TG TBD Cohort 3 or Placebo Placebo TG Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3) ASN008 TG TBD Cohort 2 or Placebo ASN008 TG Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3) 328 µg/cm2 ASN008 TG or Placebo Placebo TG Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2) 164 µg/cm2 ASN008 TG or Placebo Placebo TG PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2) 492 µg/cm2 ASN008 TG or Placebo Placebo TG Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2) 82 µg/cm2 ASN008 TG or Placebo ASN008 TG PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2) 164 µg/cm2 ASN008 TG or Placebo ASN008 TG PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2) ASN008 TG TBD Cohort 2 or Placebo Placebo TG Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3) 492 µg/cm2 ASN008 TG or Placebo ASN008 TG Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2)
- Primary Outcome Measures
Name Time Method Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B) Part A: 14 days; Part B: 22 days Analyze incidence of treatment-emergent adverse events (TEAE)
- Secondary Outcome Measures
Name Time Method Change from baseline in pruritus NRS in AD subjects (Part B) 22 days 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
Calculate the Pharmacokinetic maximum concentration (Part A and B) 7 days and 16 days Maximum concentration of ASN008 achieved after dosing
Calculate area under the plasma concentration versus time curve (Part A and B) 7 days and 16 days A plot of the concentration of ASN008 in plasma over time
Calculate the Pharmacokinetic Half-life (Part A and B) 7 days and 16 days Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%
Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B) 22 days 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
Change from baseline in Investigator Global Assessment Score in AD subjects (Part B) 22 Days 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)
Trial Locations
- Locations (5)
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Dermatology Consulting Services, PLLC
🇺🇸High Point, North Carolina, United States
Certified Research Associates
🇺🇸Cortland, New York, United States
Innovaderm Recherches Inc
🇨🇦Montréal, Quebec, Canada
Spaulding Research Clinic, Inc
🇺🇸West Bend, Wisconsin, United States