Dermatitis, AtopicPhase 1NCT03798561
Study to Evaluate ASN008 Topical Gel (TG)
A Phase 1 study testing ASN008 TG in people with Dermatitis, Atopic and Pruritus, run by Asana BioSciences at 5 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic, Pruritus, Dermatitis Eczema
- What is being tested?
- ASN008 TG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 14 Jan 2019to 20 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Certified Research Associates
Cortland, New York, 13045
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
Progressive Clinical Research
San Antonio, Texas, 78213
Spaulding Research Clinic, Inc
West Bend, Wisconsin, 53095
About this study
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
This is an ascending dose escalation study to test the safety, tolerability and preliminary efficacy of ASN008 TG in first-in-human subjects
Read the 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.
- Conditions
- Dermatitis, Atopic, Pruritus, Dermatitis Eczema
- Being tested
- ASN008 TG, Placebo TG
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASN008 TGDrug
ASN008 TG
Placebo TGDrug
Placebo TG
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: ASN008 TG; Drug: Placebo TG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Part A: 14 days; Part B: 22 days
Secondary outcomes (6)
Calculate area under the plasma concentration versus time curve (Part A and B)
A plot of the concentration of ASN008 in plasma over time
Measured: 7 days and 16 days
Calculate the Pharmacokinetic Half-life (Part A and B)
Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%
Measured: 7 days and 16 days
Calculate the Pharmacokinetic maximum concentration (Part A and B)
Maximum concentration of ASN008 achieved after dosing
Measured: 7 days and 16 days
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
Measured: 22 days
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
Measured: 22 days
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)
Measured: 22 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start14 Jan 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asana BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niranjan Rao, PhD, Study director, Asana BioSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798561
- Sponsor's protocol ID
- ASN008-101
- Status last verified
- May 2020
- First submitted
- 4 Jan 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32616515
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03798561
- Acronym / sponsor ID
- ASN008-101
- Conditions
- Dermatitis, Atopic, Pruritus, Dermatitis Eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Asana BioSciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.
| Arm | Type | Receives |
|---|---|---|
| 82 µg/cm2 ASN008 TG or Placebo | Experimental | Drug: ASN008 TG, Drug: Placebo TGPART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2) |
| 164 µg/cm2 ASN008 TG or Placebo | Experimental | Drug: ASN008 TG, Drug: Placebo TGPART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2) |
| 328 µg/cm2 ASN008 TG or Placebo | Experimental | Drug: ASN008 TG, Drug: Placebo TGPart A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2) |
| 492 µg/cm2 ASN008 TG or Placebo | Experimental | Drug: ASN008 TG, Drug: Placebo TGPart A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2) |
| ASN008 TG TBD Cohort 1 or Placebo | Experimental | Drug: ASN008 TG, Drug: Placebo TGPart B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3) |
| ASN008 TG TBD Cohort 2 or Placebo | Experimental | Drug: ASN008 TG, Drug: Placebo TGPart B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3) |
| ASN008 TG TBD Cohort 3 or Placebo | Experimental | Drug: ASN008 TG, Drug: Placebo TGPart B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASN008 TGASN008 TG | Drug | 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 TGPlacebo TG | Drug | 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 |
Primary outcome
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)
6 secondary outcomes
Calculate area under the plasma concentration versus time curve (Part A and B)
Time frame: 7 days and 16 days
Calculate the Pharmacokinetic Half-life (Part A and B)
Time frame: 7 days and 16 days
Calculate the Pharmacokinetic maximum concentration (Part A and B)
Time frame: 7 days and 16 days
Change from baseline in pruritus NRS in AD subjects (Part B)
Time frame: 22 days
Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B)
Time frame: 22 days
Change from baseline in Investigator Global Assessment Score in AD subjects (Part B)
Time frame: 22 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 32616515Ramachandran 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.
- Individual participant dataSharing planned: No
Related trials for Dermatitis, Atopic
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
Active, not recruitingPhase 4
DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Atopic Dermatitis, Atopic Dermatitis Eczema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niranjan Rao, PhD study director
Asana BioSciences
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASN008 TG in people with Dermatitis, Atopic and Pruritus, run by Asana BioSciences at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.