Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome

Part of paid clinical trials in Palo Alto, California.

Sponsor
Azitra Inc.
Study ID
NCT06137157
Phase
PHASE1
Status
Recruiting
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Conditions

  • Netherton Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATR12-351 — DRUG
    Topical ointment containing ATR12-351, a LEKTI-secreting strain of S. epidermidis

Study Details

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.

Key Dates

Start date
Jun 19, 2024
Status verified
Feb 2026
Primary completion
Jun 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Adverse events [ Time Frame: 84 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Estephannie, Study Coordinator
[email protected]
650-387-0419
Jean Y Tang, MD PhD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06519-

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By research site
Stanford University· Palo Alto, CAYale University· New Haven, CT

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