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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTO-3712 single dose IV | Experimental | ATTO-3712 Dose level cohorts receiving a single dose IV |
|
| Placebo single dose IV | Placebo Comparator | Placebo preparation to match Experimental Arm with single dose IV |
|
| ATTO-3712 single dose SC | Experimental | ATTO-3712 dose level cohorts receiving a single dose SC |
|
| Placebo single dose SC | Placebo Comparator | Placebo preparation to match Experimental Arm with single dose SC |
|
| ATTO-3712 multiple dose SC | Experimental | ATTO-3712 administered to dose level cohorts in multiple SC doses |
|
| Placebo multiple dose SC | Placebo Comparator | Placebo preparation to match Experimental Arm administered in multiple SC doses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTO-3712 | Drug | ATTO-3712 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs | 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. | 0-113 Days for SAD; 0-143 Days for MAD |
| Incidence of laboratory abnormalities | Clinical laboratory parameters (hematologic and blood chemistry) will be summarized by visit | 0-113 Days for SAD; 0-143 days for MAD |
| Incidence of ECG abnormalities | ECG findings (including QT abnormalities) will be summarized by visit. | 0-113 Days for SAD; 0-143 Days for MAD |
| Incidence of vital sign abnormalities | Vital signs (systolic and diastolic blood pressure, temperature, heart rate) will be summarized by visit. | 0-113 Days for SAD; 0-143 Days for MAD |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Anti-Drug Antibodies | 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. | 0-113 Days for SAD; 0-143 Days for MAD |
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Parts 1&2 (Healthy Volunteers) Key Inclusion Criteria:
Part 3 (Participants with Atopic Dermatitis) Key Inclusion Criteria:
Parts 1 & 2 (Healthy Volunteers) Key Exclusion Criteria
Part 3 (Participants with Atopic Dermatitis) Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Attovia Clinical Site 203 | Encinitas | California | 92024 | United States | ||
| Attovia Clinical Site 202 |
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Single ascending dose, multiple ascending dose, randomized, double-blind, placebo-controlled
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|
| Placebo | Drug | Placebo preparation to match ATTO-3712 dose |
|
| Peak plasma concentration (Cmax) ATTO-3712 | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include maximum concentration (Cmax) of ATTO-3712 | 0-113 Days for SAD; 0-143 Days for MAD |
| Circulating half-life of ATTO-3712 (t1/2) | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include half-life (t1/2) of ATTO-3712. | 0-113 Days for SAD; 0-143 Days for MAD |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include area under the plasma concentration-time curve (AUC). | 0-113 Days for SAD; 0-143 Days for MAD |
| Clearance Rate (C) of ATTO-3712 | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include characterization of the clearance rate (C) of ATTO-3712. | 0-113 Days for SAD; 0-143 Days for MAD |
| Volume of Distribution (V) of ATTO-3712 | 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. | 0-113 Days for SAD; 0-143 Days for MAD |
| Bioavailability (F) of ATTO-3712 | The pharmacokinetics of single and multiple dose levels of ATTO-3712 in participants will include characterization of the Bioavailability (F) of ATTO-3712. | 0-113 Days for SAD; 0-143 Days for MAD |
| Saint Joseph |
| Missouri |
| 64506 |
| United States |
| Attovia Clinical Site 102 | Peterborough | Ontario | K9J 5K2 | Canada |
| Altasciences | Montreal | Quebec | H3P 3P1 | Canada |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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