Clincosm LogoSign in Get a demo

Study to Evaluate ASN008 Topical Gel (TG)

Sponsor
Asana BioSciences (Industry)
Overall Status
Completed
CT.gov ID
NCT03798561
Collaborator
(none)
24
Enrollment
5
Locations
7
Arms
14.2
Actual Duration (Months)
4.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.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 :
Jan 14, 2019
Actual Primary Completion Date :
Mar 20, 2020
Actual Study Completion Date :
Mar 20, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B) [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) [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) [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) [7 days and 16 days]

    Maximum concentration of ASN008 achieved after dosing

  4. Change from baseline in pruritus NRS in AD subjects (Part B) [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) [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) [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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Certified Research Associates Cortland New York United States 13045
2 Dermatology Consulting Services, PLLC High Point North Carolina United States 27262
3 Progressive Clinical Research San Antonio Texas United States 78213
4 Spaulding Research Clinic, Inc West Bend Wisconsin United States 53095
5 Innovaderm Recherches Inc Montréal Quebec Canada H2K4L5

Sponsors and Collaborators

  • Asana BioSciences

Investigators

  • Study Director: Niranjan Rao, PhD, Asana BioSciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asana BioSciences
ClinicalTrials.gov Identifier:
NCT03798561
Other Study ID Numbers:
  • ASN008-101
First Posted:
Jan 10, 2019
Last Update Posted:
May 28, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Pruritus

Study Results

No Results Posted as of May 28, 2020