A Randomized, Double -Blind, Placebo-Controlled, Sequential, Multiple-Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of ASN002 In Subjects With Moderate-To-Severe Atopic Dermatitis
Overview
- Phase
- Phase 1
- Intervention
- ASN002
- Conditions
- Dermatitis, Atopic
- Sponsor
- Asana BioSciences
- Enrollment
- 36
- Locations
- 10
- Primary Endpoint
- Determine the maximum tolerated dose of ASN002
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).
Detailed Description
This study is a dose escalation study to determine a safe and tolerable dose of ASN002 for people with moderate to severe atopic dermatitis. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and skin biopsies. Subjects will also be assessed for improvement in their atopic dermatitis. There will be a screening period (up to 30 days) and a treatment period for 4 weeks with a 14 day follow up with an end-of-study visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ASN002 40 mg
40 mg ASN002
Intervention: ASN002
ASN002 40 mg
40 mg ASN002
Intervention: Placebo Oral Tablet
ASN002 80 mg
80 mg ASN002
Intervention: ASN002
ASN002 80 mg
80 mg ASN002
Intervention: Placebo Oral Tablet
ASN002 20 mg
20 mg ASN002
Intervention: ASN002
ASN002 20 mg
20 mg ASN002
Intervention: Placebo Oral Tablet
ASN002 120 mg
120 mg ASN002
Intervention: ASN002
ASN002 120 mg
120 mg ASN002
Intervention: Placebo Oral Tablet
Outcomes
Primary Outcomes
Determine the maximum tolerated dose of ASN002
Time Frame: 43 days
Analyze the number and type of adverse events reported.
Secondary Outcomes
- Calculate the area under the plasma concentration versus time curve(16 Days)
- Calculate the Pharmacokinetic Half-life(16 Days)
- Change from baseline in the subject-reported puritis (itch) score(28 days)
- Change from baseline in EASI score(28 days)
- Calculate the Pharmacokinetic maximum concentration(16 Days)
- Change from baseline in the Investigator Global Assessment(28 days)