Status:
COMPLETED
Study to Evaluate ASN008 Topical Gel (TG)
Lead Sponsor:
Asana BioSciences
Conditions:
Dermatitis, Atopic
Pruritus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 volu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03798561
Start Date
January 14 2019
End Date
March 20 2020
Last Update
May 9 2023
Active Locations (5)
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1
Certified Research Associates
Cortland, New York, United States, 13045
2
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States, 27262
3
Progressive Clinical Research
San Antonio, Texas, United States, 78213
4
Spaulding Research Clinic, Inc
West Bend, Wisconsin, United States, 53095