Atopic Dermatitis (AD), Atopic Eczema, Atopic Eczema/Dermatitis (Non-Specific), Normal Volunteers
Conditions
Keywords
Atopic Dermatitis, AD, Atopic Eczema, Ecema, Itch, Pruritus
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 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.
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 will consist of multiple doses in adult patients with atopic dermatitis to assess safety, tolerability, PK, and PD based on biomarkers in the blood.
Interventions
DRUGATTO-3712
ATTO-3712
DRUGPlacebo
Placebo preparation to match ATTO-3712 dose
Sponsors
Attovia Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Single ascending dose, multiple ascending dose, randomized, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs | 0-113 Days for SAD; 0-143 Days for MAD | The primary analysis will describe the incidence of AEs and laboratory abnormalities. AEs will be coded according to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA, version 28.0 or the current version). Their severity will be graded using the NCI CTCAE v5.0 or the current version. |
| Incidence of laboratory abnormalities | 0-113 Days for SAD; 0-143 days for MAD | Clinical laboratory parameters (hematologic and blood chemistry) will be summarized by visit |
| Incidence of ECG abnormalities | 0-113 Days for SAD; 0-143 Days for MAD | ECG findings (including QT abnormalities) will be summarized by visit. |
| Incidence of vital sign abnormalities | 0-113 Days for SAD; 0-143 Days for MAD | Vital signs (systolic and diastolic blood pressure, temperature, heart rate) will be summarized by visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Anti-Drug Antibodies | 0-113 Days for SAD; 0-143 Days for MAD | Baseline prevelance of ADA, changes in ADA status from prior to the first dose of IP to each applicable post-dose timepoint and ADA titer values for samples confirmed positive for ADA will be evaluated to assess the immunogenicity of single and multiple dose levels of ATT-3712. |
| Peak plasma concentration (Cmax) ATTO-3712 | 0-113 Days for SAD; 0-143 Days for MAD | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include maximum concentration (Cmax) of ATTO-3712 |
| Circulating half-life of ATTO-3712 (t1/2) | 0-113 Days for SAD; 0-143 Days for MAD | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include half-life (t1/2) of ATTO-3712. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | 0-113 Days for SAD; 0-143 Days for MAD | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include area under the plasma concentration-time curve (AUC). |
| Clearance Rate (C) of ATTO-3712 | 0-113 Days for SAD; 0-143 Days for MAD | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include characterization of the clearance rate (C) of ATTO-3712. |
| Volume of Distribution (V) of ATTO-3712 | 0-113 Days for SAD; 0-143 Days for MAD | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include characterization of the Volume of distribution (V) of ATTO-3712. |
| Bioavailability (F) of ATTO-3712 | 0-113 Days for SAD; 0-143 Days for MAD | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include characterization of the Bioavailability (F) of ATTO-3712. |
Countries
Canada, New Zealand, United States
Outcome results
None listed