NCT06787586

Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and PK of ATTO1310 in Adult Volunteers, Patients With Atopic Dermatitis, and Patients With Chronic Pruritus

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Attovia Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-1310 in healthy adults, patients with atopic dermatitis and patients with chronic pruritus. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-1310? How long does ATTO-1310 stay in the body after dosing? Researchers will compare ATTO-1310 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1310 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.

Detailed description

This is a 4-part study. Parts 1 and 2 will be a single and multiple ascending dose design, respectively, assessing the safety, tolerability and PK of ATTO-1310 in healthy adult volunteers. Part 3 and Part 4 will consist of a single dose in adult patients with atopic dermatitis or chronic pruritus, respectively, to assess safety, tolerability, PK, and PD based on biomarkers in the blood.

Conditions

• Normal Volunteers
• Atopic Dermatitis (AD)
• Atopic Eczema
• Chronic Pruritus

Interventions

Type	Name	Description
DRUG	ATTO-1310	ATTO-1310 Attobody
DRUG	ATTO-1310 Placebo	Placebo preparation to match ATTO-1310 Dose

Timeline

• Start date: 2025-01-14
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-01-22
• Last updated: 2026-03-05

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study