study to evaluate asn008 topical gel (tg)

Conditions: Dermatitis, Atopic; Pruritus; Dermatitis Eczema

Summary: 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.

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