Study to Evaluate ASN008 Topical Gel (TG)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-03-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dermatitis, Atopic Pruritus Dermatitis Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded

Study Groups

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82 µg/cm2 ASN008 TG 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)

Group Type EXPERIMENTAL

ASN008 TG

Intervention Type DRUG

ASN008 TG

Placebo TG

Intervention Type DRUG

Placebo TG

164 µg/cm2 ASN008 TG or Placebo

PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2)

Group Type EXPERIMENTAL

ASN008 TG

Intervention Type DRUG

ASN008 TG

Placebo TG

Intervention Type DRUG

Placebo TG

328 µg/cm2 ASN008 TG or Placebo

Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2)

Group Type EXPERIMENTAL

ASN008 TG

Intervention Type DRUG

ASN008 TG

Placebo TG

Intervention Type DRUG

Placebo TG

492 µg/cm2 ASN008 TG or Placebo

Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2)

Group Type EXPERIMENTAL

ASN008 TG

Intervention Type DRUG

ASN008 TG

Placebo TG

Intervention Type DRUG

Placebo TG

ASN008 TG TBD Cohort 1 or Placebo

Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3)

Group Type EXPERIMENTAL

ASN008 TG

Intervention Type DRUG

ASN008 TG

Placebo TG

Intervention Type DRUG

Placebo TG

ASN008 TG TBD Cohort 2 or Placebo

Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3)

Group Type EXPERIMENTAL

ASN008 TG

Intervention Type DRUG

ASN008 TG

Placebo TG

Intervention Type DRUG

Placebo TG

ASN008 TG TBD Cohort 3 or Placebo

Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3)

Group Type EXPERIMENTAL

ASN008 TG

Intervention Type DRUG

ASN008 TG

Placebo TG

Intervention Type DRUG

Placebo TG

Interventions

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ASN008 TG

Intervention Type DRUG

Placebo TG

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes