← Back to all trials
Completed
NCT07205081
Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis
Conditions: Normal Volunteers, Atopic Dermatitis (AD), Atopic Eczema, Atopic Eczema/Dermatitis (Non-Specific)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 48
Sponsor: Attovia Therapeutics Inc
Location: Attovia Clinical Site 203 Encinitas California
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 Criteria
Parts 1\&2 (Healthy Volunteers) Key Inclusion Criteria:
* 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 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
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT07205081). StuddyBuddy aggregates publicly available trial information.