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Study to Evaluate ASN008 Topical Gel (TG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03798561
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : May 9, 2023
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences

Study Description
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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

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Pruritus Dermatitis Eczema Drug: ASN008 TG Drug: Placebo TG Phase 1

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 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.
Masking: Double (Participant, Investigator)
Masking Description: Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Vehicle-Controlled Ascending Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASN008 Topical Gel in Healthy Volunteers and Subjects With Atopic Dermatitis
Actual Study Start Date : January 14, 2019
Actual Primary Completion Date : March 20, 2020
Actual Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Asparagine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 Drug: ASN008 TG
ASN008 TG

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

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

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

Drug: Placebo TG
Placebo TG
Experimental: 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)
 Drug: ASN008 TG
ASN008 TG

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

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

Drug: Placebo TG
Placebo TG


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B) [ Time Frame: Part A: 14 days; Part B: 22 days ]
    Analyze incidence of treatment-emergent adverse events (TEAE)


Secondary Outcome Measures :
  1. Calculate area under the plasma concentration versus time curve (Part A and B) [ Time Frame: 7 days and 16 days ]
    A plot of the concentration of ASN008 in plasma over time

  2. Calculate the Pharmacokinetic Half-life (Part A and B) [ Time Frame: 7 days and 16 days ]
    Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%

  3. Calculate the Pharmacokinetic maximum concentration (Part A and B) [ Time Frame: 7 days and 16 days ]
    Maximum concentration of ASN008 achieved after dosing

  4. Change from baseline in pruritus NRS in AD subjects (Part B) [ Time Frame: 22 days ]
    Numeric Rating Scale ranging from 0 to 10; 0 indicates no itching; 10 indicates worst possible itching; Rating of pruritis based degree, duration, direction, disability, and distribution

  5. Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B) [ Time Frame: 22 days ]
    Measurement of area and severity of atopic dermatitis based on composite score 0 to 72 encompassing degree of erythema, induration, excoriation and lichenification; each scored from 0 to 3 with 0 indicating none and 3 indicating severe

  6. Change from baseline in Investigator Global Assessment Score in AD subjects (Part B) [ Time Frame: 22 Days ]
    5 point morphological assessment of overall disease severity scored from 0 to 4 with 0 indicating clear (no inflammation) and 4 indicating severe (marked erythema)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798561


Locations
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United States, New York
Certified Research Associates
Cortland, New York, United States, 13045
United States, North Carolina
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States, 27262
United States, Texas
Progressive Clinical Research
San Antonio, Texas, United States, 78213
United States, Wisconsin
Spaulding Research Clinic, Inc
West Bend, Wisconsin, United States, 53095
Canada, Quebec
Innovaderm Recherches Inc
Montréal, Quebec, Canada, H2K4L5
Sponsors and Collaborators
Asana BioSciences
Investigators
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Study Director: Niranjan Rao, PhD Asana BioSciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Asana BioSciences
ClinicalTrials.gov Identifier: NCT03798561    
Other Study ID Numbers: ASN008-101
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Pruritus
Skin Diseases
Skin Diseases, Eczematous
Skin Manifestations
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases