NCT03798561

Study to Evaluate ASN008 Topical Gel (TG)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Asana BioSciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Dermatitis, Atopic
• Pruritus
• Dermatitis Eczema

Interventions

Type	Name	Description
DRUG	ASN008 TG	ASN008 TG
DRUG	Placebo TG	Placebo TG

Timeline

• Start date: 2019-01-14
• Primary completion: 2020-03-20
• Completion: 2020-03-20
• First posted: 2019-01-10
• Last updated: 2023-05-09

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study