Study to Evaluate ASN008 Topical Gel (TG)

NCT03798561 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ASN008-101
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 5

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

Conditions

Dermatitis, Atopic; Pruritus; Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• 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)

  Part A: 14 days; Part B: 22 days

Secondary Outcomes (6)

• Calculate area under the plasma concentration versus time curve (Part A and B)

  7 days and 16 days

• Calculate the Pharmacokinetic Half-life (Part A and B)

  7 days and 16 days

• Calculate the Pharmacokinetic maximum concentration (Part A and B)

  7 days and 16 days

• Change from baseline in pruritus NRS in AD subjects (Part B)

  22 days

• Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B)

  22 days

Study Arms (7)

82 µg/cm2 ASN008 TG or Placebo

EXPERIMENTAL

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; Drug: Placebo TG

164 µg/cm2 ASN008 TG or Placebo

EXPERIMENTAL

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

Drug: ASN008 TG; Drug: Placebo TG

328 µg/cm2 ASN008 TG or Placebo

EXPERIMENTAL

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

Drug: ASN008 TG; Drug: Placebo TG

492 µg/cm2 ASN008 TG or Placebo

EXPERIMENTAL

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

Drug: ASN008 TG; Drug: Placebo TG

ASN008 TG TBD Cohort 1 or Placebo

EXPERIMENTAL

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

Drug: ASN008 TG; Drug: Placebo TG

ASN008 TG TBD Cohort 2 or Placebo

EXPERIMENTAL

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

Drug: ASN008 TG; Drug: Placebo TG

ASN008 TG TBD Cohort 3 or Placebo

EXPERIMENTAL

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

Drug: ASN008 TG; Drug: Placebo TG

Interventions

ASN008 TG DRUG

ASN008 TG

164 µg/cm2 ASN008 TG or Placebo; 328 µg/cm2 ASN008 TG or Placebo; 492 µg/cm2 ASN008 TG or Placebo; 82 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

Placebo TG DRUG

Placebo TG

164 µg/cm2 ASN008 TG or Placebo; 328 µg/cm2 ASN008 TG or Placebo; 492 µg/cm2 ASN008 TG or Placebo; 82 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asana BioSciences: lead

Study Sites (5)

Certified Research Associates

Cortland, New York, 13045, United States

Location

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Spaulding Research Clinic, Inc

West Bend, Wisconsin, 53095, United States

Location

Innovaderm Recherches Inc

Montreal, Quebec, H2K4L5, Canada

Location

Related Publications (1)

• 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.

  PMID: 32616515 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Niranjan Rao, PhD

  Asana BioSciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 10, 2019
• Study Start: January 14, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: May 9, 2023

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4)