A Randomized, Double-Blind, Vehicle-Controlled, First-in-Human Safety, Tolerability and Proof-of-Concept Study of Topical ATR12-351 in Adults with Netherton Syndrome
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The objectives of this clinical trial are to evaluate the safety and tolerability of topically applied ATR12-351, to understand what the body does to ATR12-351, and to observe treatment benefits of the drug in approximately 12 adult patients with Netherton Syndrome (NS). ATR12-351 will be applied to skin lesions on one side of the body, while the vehicle control will be applied to similar lesion on the other side of the body twice daily for 2 weeks.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults ≥18 years of age
• Confirmed mutation of the serine protease inhibitor of Kazal type 5 (SPINK5) gene
• Involvement of ≥20% of body surface area with skin changes consistent with Netherton syndrome
Locations
United States
California
Stanford University
RECRUITING
Palo Alto
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Travis Whitfill
clinicaltrials@azitrainc.com
203-646-6446
Time Frame
Start Date: 2024-06-19
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 12
Treatments
Experimental: Internal controlled arm
ATR12-351 on left side of body, vehicle on right side of body in one group; vehicle on left side of body, ATR12-351 on right side of body.
Related Therapeutic Areas
Sponsors
Leads: Azitra Inc.