Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus
NCT ID: NCT06787586
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
104 participants
INTERVENTIONAL
2025-01-14
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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ATTO-1310 Placebo multiple dose SC
Placebo preparation to match Experimental Arm administered in multiple SC doses
ATTO-1310 Placebo
Placebo preparation to match ATTO-1310 Dose
ATTO-1310 single dose IV
ATTO-1310 Attobody Dose level cohorts receiving a single dose IV
ATTO-1310
ATTO-1310 Attobody
ATTO-1310 Placebo single dose IV
Placebo preparation to match Experimental Arm with single dose IV
ATTO-1310 Placebo
Placebo preparation to match ATTO-1310 Dose
ATTO-1310 single dose SC
ATTO-1310 Attobody Dose level cohorts receiving a single dose SC
ATTO-1310
ATTO-1310 Attobody
ATTO-1310 Placebo single dose SC
Placebo preparation to match Experimental Arm with single dose SC
ATTO-1310 Placebo
Placebo preparation to match ATTO-1310 Dose
ATTO-1310 multiple dose SC
ATTO-1310 Attobody administered to dose level cohorts in multiple SC doses
ATTO-1310
ATTO-1310 Attobody
Interventions
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ATTO-1310
ATTO-1310 Attobody
ATTO-1310 Placebo
Placebo preparation to match ATTO-1310 Dose
Eligibility Criteria
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Inclusion Criteria
* 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 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
* At least a 1-year history of AD and had no significant flares in AD for at least 4 weeks before Screening
* Baseline weekly mean of daily PP-NRS ≥ 7 at Day 1
* EASI score of ≥ 7 at Screening and Day 1
* vIGA-AD score of ≥ 3 at Screening and Day 1
* Use of topical bland emollient (moisturizer) once or twice 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 subjects of child-bearing potential
* Use of highly effective forms of birth control
* Any sex or gender who is 18 to 85 years old
* Body weight of 50 to 125 kg, inclusive, and BMI between 18.5 and 40 kg/m2
* Has had chronic pruritus for at least 6 months and is unresponsive to at least a 2-week course of emollient use.
* Chronic pruritus that affects at least 2 of the following body areas: legs, arms, or trunk
* A single PP-NRS score of ≥ 5 in the 24-hour period prior to the Screening visit
* Baseline weekly mean of daily PP-NRS ≥ 7 at Day 1
* Use of a stable dose of topical bland emollient (moisturizer) once or twice daily for at least 2 weeks before Day 1 and agrees to continue using that same emollient at the same frequency throughout the study
* Negative pregnancy test for subjects of child-bearing potential
* Use of highly effective forms of birth control
Exclusion Criteria
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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Attovia Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Sicard, MD
Role: PRINCIPAL_INVESTIGATOR
Altasciences Company Inc.
Locations
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Attovia Clinical Site 103
Encinitas, California, United States
Attovia Clinical Site 116
Rocklin, California, United States
Attovia Clinical Site 107
Sacramento, California, United States
Attovia Clinical Site 109
Coral Gables, Florida, United States
Attovia Clinical Site 102
Plainfield, Indiana, United States
Attovia Clinical Site 104
Saint Joseph, Missouri, United States
Attovia Clinical Site 106
Reno, Nevada, United States
Attovia Clinical Site 114
New York, New York, United States
Attovia Clinical Site 108
San Antonio, Texas, United States
Attovia Clinical Site 110
Fredericton, New Brunswick, Canada
Attovia Clinical Site 111
Newmarket, Ontario, Canada
Attovia Clinical Site 112
Peterborough, Ontario, Canada
Attovia Clinical Site 113
Toronto, Ontario, Canada
Attovia Clinical Site 105
Montreal, Quebec, Canada
Altasciences
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Study Research Coordinator
Role: primary
Research Study Coordinator
Role: primary
Research Study Coordinator
Role: primary
Study Research Coordinator
Role: primary
Study Research Coordinator
Role: primary
Study Research Coordinator
Role: primary
Study Research Coordinator
Role: primary
Study Research Coordinator
Role: primary
Study Research Coordinator
Role: primary
Research Study Coordinator
Role: primary
Research Study Coordinator
Role: primary
Research Study Coordinator
Role: primary
Study Research Coordinator
Role: primary
Other Identifiers
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ATTO-1310-101
Identifier Type: -
Identifier Source: org_study_id
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