Study to Evaluate ASN008 Topical Gel (TG)
Dermatitis, Atopic, Pruritus, Dermatitis Eczema
About this trial
This is an interventional treatment trial for Dermatitis, Atopic
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- Certified Research Associates
- Dermatology Consulting Services, PLLC
- Progressive Clinical Research
- Spaulding Research Clinic, Inc
- Innovaderm Recherches Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
82 µg/cm2 ASN008 TG or Placebo
164 µg/cm2 ASN008 TG or Placebo
328 µg/cm2 ASN008 TG or Placebo
492 µg/cm2 ASN008 TG or Placebo
ASN008 TG TBD Cohort 1 or Placebo
ASN008 TG TBD Cohort 2 or Placebo
ASN008 TG TBD Cohort 3 or Placebo
PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2)
PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2)
Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2)
Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2)
Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3)
Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3)
Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3)