Status:
RECRUITING
Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis
Lead Sponsor:
Attovia Therapeutics Inc
Conditions:
Normal Volunteers
Atopic Dermatitis (AD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 ar...
Detailed Description
This is a 3-part study. Parts 1 and 2 will be a single and multiple ascending dose design, respectively, assessing the safety, tolerability, and PK of ATTO-3712 in healthy adult volunteers. Part 3 wil...
Eligibility Criteria
Inclusion
- Parts 1\&2 (Healthy Volunteers) Key
- 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.
- Part 3 (Participants with Atopic Dermatitis) Key
- 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
- Parts 1 \& 2 (Healthy Volunteers) Key Exclusion Criteria
- 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
- Part 3 (Participants with Atopic Dermatitis) Key
Exclusion
- 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
Key Trial Info
Start Date :
October 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07205081
Start Date
October 22 2025
End Date
October 1 2026
Last Update
November 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altasciences
Montreal, Quebec, Canada, H3P 3P1