Actively Recruiting
Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis
Led by Attovia Therapeutics Inc · Updated on 2025-11-21
72
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-3712 in healthy adults and patients with atopic dermatitis. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-3712? How long does ATTO-3712 stay in the body after dosing? Researchers will compare ATTO-3712 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-3712 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.
CONDITIONS
Official Title
Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years old
- Body weight between 50 and 125 kg
- Body mass index (BMI) between 18.5 and 35 kg/m2 for healthy volunteers; between 18.5 and 40 kg/m2 for patients with atopic dermatitis
- In good general health based on medical history, physical exam, ECG, lab tests, and vital signs (for healthy volunteers)
- Negative pregnancy test for participants who can become pregnant
- Clinically confirmed active atopic dermatitis (for patients)
- History of inadequate response to topical treatments (for patients)
- Baseline weekly mean daily itch score of 4 or higher on PP-NRS at Day 1 (for patients)
- Eczema Area and Severity Index (EASI) score of 16 or higher at Screening and Day 1 (for patients)
- Investigator global assessment score of 3 or higher at Screening and Day 1 (for patients)
- At least 10% of body surface area affected by atopic dermatitis at Screening and Day 1 (for patients)
- Use of bland moisturizer daily for at least 5 of 7 days before Day 1 and agreement to continue during study (for patients)
You will not qualify if you...
- Any significant underlying illness
- History of cancer within 5 years before screening
- Major surgery within 8 weeks before Day 1 or planned during study
- Uncontrolled asthma requiring rescue treatment more than twice per week
- History of severe allergy or anaphylaxis to biologics, vaccines, immunoglobulins, or study drug ingredients
- Active hepatitis B or C infection or positive HIV status
- Active or latent tuberculosis infection
- Smoking more than 20 cigarettes or equivalent per day
- History of drug or alcohol abuse
- Abnormal lab test results
- Skin conditions interfering with study assessments (for patients)
- Use of prohibited medications for atopic dermatitis within restricted times
- Use of topical corticosteroids within 2 weeks before dosing (for patients)
- History of recurrent eczema herpeticum
- Known primary immunodeficiency or immunocompromised status
- Untreated latent tuberculosis or recent treatment for active tuberculosis or parasites
- History of major depression
- Significant disease flare within 2 weeks before screening or during screening (for patients)
- More than doubling of EASI score between screening and Day 1 (for patients)
- Abnormal ECG with prolonged QT interval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Altasciences
Montreal, Quebec, Canada, H3P 3P1
Actively Recruiting
Research Team
M
Malinda Longphre, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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