Study to Evaluate ASN008 Topical Gel (TG)

• Status: Completed
• Trial end date: 2020-03-20
• Target enrollment: 0
• Participant gender: All

Summary

This is an ascending dose escalation study to test the safety, tolerability and preliminary efficacy of ASN008 TG in first-in-human subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asana BioSciences

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