Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ATTO-3712 in Healthy Adult Volunteers and Patients With Atopic Dermatitis
Attovia Therapeutics Inc
72 participants
Oct 22, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria14
- Any sex or gender who is 18 to 65 years old, inclusive, at Screening.
- 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 participants of child-bearing potential.
- 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
- History of inadequate response to treatment with topical medications
- Baseline weekly mean of daily PP-NRS ≥ 4 at Day 1.
- EASI score of ≥ 16 at Screening and Day 1
- vIGA-AD score of ≥ 3 at Screening and Day 1
- ≥10% of body surface area (BSA) affected by AD at Screening and Day 1
- Use of topical bland emollient (moisturizer) at least once 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 participants of childbearing potential
Exclusion Criteria28
- Any clinically significant underlying illness
- History of malignancy within 5 years of Screening
- History of major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
- History of uncontrolled asthma requiring rescue treatment with a bronchodilator for an increase in symptoms more than twice per week
- History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or is positive for HIV
- Active or latent tuberculosis infection
- Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
- History of drug or alcohol abuse
- Laboratory values outside of the normal range
- Any clinically significant underlying illness
- Presence of skin comorbidities that may interfere with study assessments
- Has taken prescription medication for the treatment of AD or other prohibited medication within the restricted time limits (defined in the protocol)
- Has applied topical corticosteroids within 2 weeks prior to dosing.
- History of malignancy within 5 years of Screening
- History of major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
- History of uncontrolled asthma requiring rescue treatment with a bronchodilator for an increase in symptoms more than twice per week
- History of recurrent eczema herpeticum
- History of known primary immunodeficiency, is considered immunocompromised, history of untreated latent tuberculosis infection, has been treated for active tuberculosis in the past year, or has been treated for a parasitic infection in the past 6 months
- History of major depression
- History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients (sucrose, polysorbate 80, or histidine)
- Participant has experienced significant flare(s) in AD in the 2 weeks prior to Screening or during the Screening period
- EASI score for the participant has more than doubled between Screening and Day 1
- Active HBV or HCV or is positive for HIV
- Participant is smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent to approximately 40 mg nicotine) per day
- Participant has an ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening
- History of drug or alcohol abuse
- Laboratory values outside of the normal range
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Interventions
ATTO-3712
Placebo preparation to match ATTO-3712 dose
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07205081