RECRUITING

Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus

Conditions

Normal Volunteers Atopic Dermatitis (AD)Atopic Eczema Chronic Pruritus Atopic dermatitis AD Eczema Chronic pruritis Itch Pruritus

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-1310 in healthy adults, patients with atopic dermatitis and patients with chronic pruritus. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-1310? How long does ATTO-1310 stay in the body after dosing? Researchers will compare ATTO-1310 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1310 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.

Official Title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and PK of ATTO1310 in Adult Volunteers, Patients With Atopic Dermatitis, and Patients With Chronic Pruritus

Quick Facts

Study Start:2025-01-14

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06787586

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Any sex or gender who is 18 to 65 years old * 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 subjects of child-bearing potential * Use of highly effective forms of birth control	* Any clinically significant underlying illness. * History of malignancy within 5 years of Screening, except adequately treated basal carcinoma or in situ carcinoma of the cervix. * History of major surgery within 8 weeks prior to Day 1 * History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy * 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 * History of a clearly defined etiology for pruritus other than AD, including but not limited to urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection * 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 asthma requiring regular use of a bronchodilator or a daily maintenance therapy * 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) * Active HBV or HCV or is positive for HIV * Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day * ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening * History of drug or alcohol abuse * Subject has applied topical corticosteroid in the 14 days preceding Day 1 * Subject has used prohibited medications or therapies during the specified washout period before Day 1 (as defined in the protocol) * Laboratory values outside of the normal range * Primary dermatologic diagnosis associated with pruritic skin lesions at the time of screening * Regional neuropathic disease associated with pruritus * Severe renal failure requiring dialysis * Untreated cholestatic liver disease * Liver function tests (bilirubin, AST, ALT, alkaline phosphatase) \>2.5 times above the upper limit of normal * History of infectious dermatoses * Suspected diagnosis of somatoform pruritus * Suspected diagnosis of drug-induced pruritus * History of malignancy within 5 years of Screening * History of unexplained fevers, night sweats, or unintentional weight loss * Major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study * History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy * History of known primary immunodeficiency, is considered immunocompromised, 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 attempted suicide * 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 HBV or HCV or is positive for HIV. * Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day * ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening * History of drug or alcohol abuse * Use of prohibited medications as defined in the Protocol

Inclusion Criteria

Exclusion Criteria

* Any sex or gender who is 18 to 65 years old
* 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 subjects of child-bearing potential
* Use of highly effective forms of birth control

* Any clinically significant underlying illness.
* History of malignancy within 5 years of Screening, except adequately treated basal carcinoma or in situ carcinoma of the cervix.
* History of major surgery within 8 weeks prior to Day 1
* History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
* 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
* History of a clearly defined etiology for pruritus other than AD, including but not limited to urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
* 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 asthma requiring regular use of a bronchodilator or a daily maintenance therapy
* 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)
* Active HBV or HCV or is positive for HIV
* Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
* ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening
* History of drug or alcohol abuse
* Subject has applied topical corticosteroid in the 14 days preceding Day 1
* Subject has used prohibited medications or therapies during the specified washout period before Day 1 (as defined in the protocol)
* Laboratory values outside of the normal range
* Primary dermatologic diagnosis associated with pruritic skin lesions at the time of screening
* Regional neuropathic disease associated with pruritus
* Severe renal failure requiring dialysis
* Untreated cholestatic liver disease
* Liver function tests (bilirubin, AST, ALT, alkaline phosphatase) \>2.5 times above the upper limit of normal
* History of infectious dermatoses
* Suspected diagnosis of somatoform pruritus
* Suspected diagnosis of drug-induced pruritus
* History of malignancy within 5 years of Screening
* History of unexplained fevers, night sweats, or unintentional weight loss
* Major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study
* History of asthma requiring regular use of a bronchodilator or a daily maintenance therapy
* History of known primary immunodeficiency, is considered immunocompromised, 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 attempted suicide
* 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 HBV or HCV or is positive for HIV.
* Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent) per day
* ECG with a QTcF \> 450 msec for males or \> 470 msec for females at Screening
* History of drug or alcohol abuse
* Use of prohibited medications as defined in the Protocol

Contacts and Locations

Study Contact

Malinda Longphre, PhD

CONTACT

+1 510-520-3361

ATTO-1310-101Clinical@attovia.com

Principal Investigator

Eric Sicard, MD

PRINCIPAL_INVESTIGATOR

Altasciences Company Inc.

Study Locations (Sites)

Attovia Clinical Site 102

Plainfield, Indiana, 46168

United States

Attovia Clinical Site 104

Saint Joseph, Missouri, 64506

United States

Attovia Clinical Site 106

Reno, Nevada, 89509

United States

Collaborators and Investigators

Sponsor: Attovia Therapeutics Inc

Eric Sicard, MD, PRINCIPAL_INVESTIGATOR, Altasciences Company Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-14

Study Completion Date2026-05

Study Record Updates

Study Start Date2025-01-14

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Atopic dermatitis
AD
Atopic eczema
Eczema
Chronic pruritis
Itch
Pruritus

Additional Relevant MeSH Terms

Normal Volunteers
Atopic Dermatitis (AD)
Atopic Eczema
Chronic Pruritus