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Study to Evaluate ASN008 Topical Gel (TG)

Primary Purpose

Dermatitis, Atopic, Pruritus, Dermatitis Eczema

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ASN008 TG
Placebo TG
Sponsored by
Asana BioSciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Certified Research Associates
  • Dermatology Consulting Services, PLLC
  • Progressive Clinical Research
  • Spaulding Research Clinic, Inc
  • Innovaderm Recherches Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

82 µg/cm2 ASN008 TG or Placebo

164 µg/cm2 ASN008 TG or Placebo

328 µg/cm2 ASN008 TG or Placebo

492 µg/cm2 ASN008 TG or Placebo

ASN008 TG TBD Cohort 1 or Placebo

ASN008 TG TBD Cohort 2 or Placebo

ASN008 TG TBD Cohort 3 or Placebo

Arm Description

PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2)

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B)
Analyze incidence of treatment-emergent adverse events (TEAE)

Secondary Outcome Measures

Calculate area under the plasma concentration versus time curve (Part A and B)
A plot of the concentration of ASN008 in plasma over time
Calculate the Pharmacokinetic Half-life (Part A and B)
Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%
Calculate the Pharmacokinetic maximum concentration (Part A and B)
Maximum concentration of ASN008 achieved after dosing
Change from baseline in pruritus NRS in AD subjects (Part B)
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
Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B)
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
Change from baseline in Investigator Global Assessment Score in AD subjects (Part B)
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)

Full Information

First Posted
January 4, 2019
Last Updated
May 8, 2023
Sponsor
Asana BioSciences
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1. Study Identification

Unique Protocol Identification Number
NCT03798561
Brief Title
Study to Evaluate ASN008 Topical Gel (TG)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asana BioSciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Pruritus, Dermatitis Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.
Masking
ParticipantInvestigator
Masking Description
Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
82 µg/cm2 ASN008 TG or Placebo
Arm Type
Experimental
Arm Description
PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2)
Arm Title
164 µg/cm2 ASN008 TG or Placebo
Arm Type
Experimental
Arm Description
PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2)
Arm Title
328 µg/cm2 ASN008 TG or Placebo
Arm Type
Experimental
Arm Description
Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2)
Arm Title
492 µg/cm2 ASN008 TG or Placebo
Arm Type
Experimental
Arm Description
Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2)
Arm Title
ASN008 TG TBD Cohort 1 or Placebo
Arm Type
Experimental
Arm Description
Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3)
Arm Title
ASN008 TG TBD Cohort 2 or Placebo
Arm Type
Experimental
Arm Description
Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3)
Arm Title
ASN008 TG TBD Cohort 3 or Placebo
Arm Type
Experimental
Arm Description
Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3)
Intervention Type
Drug
Intervention Name(s)
ASN008 TG
Intervention Description
ASN008 TG
Intervention Type
Drug
Intervention Name(s)
Placebo TG
Intervention Description
Placebo TG
Primary Outcome Measure Information:
Title
Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B)
Description
Analyze incidence of treatment-emergent adverse events (TEAE)
Time Frame
Part A: 14 days; Part B: 22 days
Secondary Outcome Measure Information:
Title
Calculate area under the plasma concentration versus time curve (Part A and B)
Description
A plot of the concentration of ASN008 in plasma over time
Time Frame
7 days and 16 days
Title
Calculate the Pharmacokinetic Half-life (Part A and B)
Description
Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%
Time Frame
7 days and 16 days
Title
Calculate the Pharmacokinetic maximum concentration (Part A and B)
Description
Maximum concentration of ASN008 achieved after dosing
Time Frame
7 days and 16 days
Title
Change from baseline in pruritus NRS in AD subjects (Part B)
Description
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
Time Frame
22 days
Title
Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B)
Description
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
Time Frame
22 days
Title
Change from baseline in Investigator Global Assessment Score in AD subjects (Part B)
Description
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)
Time Frame
22 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niranjan Rao, PhD
Organizational Affiliation
Asana BioSciences
Official's Role
Study Director
Facility Information:
Facility Name
Certified Research Associates
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Dermatology Consulting Services, PLLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Spaulding Research Clinic, Inc
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
Facility Name
Innovaderm Recherches Inc
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2K4L5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32616515
Citation
Ramachandran R, Thompson SK, Malkmus S, Mieda T, Lin JH, Gupta S, Yaksh TL. Topical Application of ASN008, a Permanently Charged Sodium Channel Blocker, Shows Robust Efficacy, a Rapid Onset, and Long Duration of Action in a Mouse Model of Pruritus. J Pharmacol Exp Ther. 2020 Sep;374(3):521-528. doi: 10.1124/jpet.120.265074. Epub 2020 Jul 2.
Results Reference
derived

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Study to Evaluate ASN008 Topical Gel (TG)

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