Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatiti… (NCT06787586) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus
United States, Canada108 participantsStarted 2025-01-14
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Parts 1 \& 2 (Healthy Volunteers) Key Inclusion Criteria:
* Any sex or gender who is 18 to 65 years old
* Body weight of 50 to 125 kg and body mass index (BMI) between 18.5 and 35 kg/m2
* Considered in good general health based on medical history, physical exam, 12-lead ECG, screening clinical laboratory findings, and vital signs
* Negative pregnancy test for subjects of child-bearing potential
* Use of highly effective forms of birth control
Part 3 (Subjects with Atopic Dermatitis) Inclusion Criteria:
* Any sex or gender who is 18 to 65 years old
* Body weight of 50 to 125 kg and BMI between 18.5 and 40 kg/m2
* Clinically confirmed diagnosis of active AD
* At least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before Screening
* Baseline weekly mean of daily PP-NRS ≥ 7 at Day 1
* EASI score of ≥ 7 at Screening and Day 1
* vIGA-AD score of ≥ 3 at Screening and Day 1
* Use of topical bland emollient (moisturizer) once or twice daily for at least 5 of the 7 days immediately before Day 1 and agrees to continue using that same emollient at the same frequency throughout the study
* Negative pregnancy test for subjects of child-bearing potential
* Use of highly effective forms of birth control
Part 4 (Subjects with Chronic Pruritus) Inclusion Criteria:
* Any sex or gender who is 18 to 85 years old
* Body weight of 50 to 125 kg, inclusive, and BMI between 18.5 and 40 kg/m2
* Has had chronic pruritus for at least 6 months and is unresponsive to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.