Study to Evaluate ASN008 Topical Gel (TG)

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798561
• Other study ID #: ASN008-101
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: May 2020
• Source: Asana BioSciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Eczema
• Dermatitis, Atopic
• Pruritus

Intervention

Drug:
• ASN008 TG
ASN008 TG
• Placebo TG
Placebo TG

Locations

Country	Name	City	State
Canada	Innovaderm Recherches Inc	Montréal	Quebec
United States	Certified Research Associates	Cortland	New York
United States	Dermatology Consulting Services, PLLC	High Point	North Carolina
United States	Progressive Clinical Research	San Antonio	Texas
United States	Spaulding Research Clinic, Inc	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Asana BioSciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Calculate area under the plasma concentration versus time curve (Part A and B)	A plot of the concentration of ASN008 in plasma over time	7 days and 16 days
Secondary	Calculate the Pharmacokinetic Half-life (Part A and B)	Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%	7 days and 16 days
Secondary	Calculate the Pharmacokinetic maximum concentration (Part A and B)	Maximum concentration of ASN008 achieved after dosing	7 days and 16 days
Secondary	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	22 days
Secondary	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	22 days
Secondary	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)	22 Days