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

NCT06787586 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ATTO-1310-101
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 17

Brief Summary

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.

Conditions

Normal Volunteers; Atopic Dermatitis (AD); Atopic Eczema; Chronic Pruritus

Keywords

Atopic dermatitis; AD; Atopic eczema; Eczema; Chronic pruritis; Itch; Pruritus

Outcome Measures

Primary Outcomes (4)

• 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 26.1 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 for each post-baseline visit.

  0-113 Days for SAD; 0-143 Days for MAD

• Incidence of ECG abnormalities

  ECG findings (including QT abnormalities) will be summarized for each post-baseline 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 for each post-baseline visit.

  0-113 Days for SAD; 0-143 Days for MAD

Secondary Outcomes (7)

• Incidence of Anti-Drug Antibodies

  0-113 Days for SAD; 0-143 Days for MAD

• Peak plasma concentration (Cmax) ATTO-1310

  0-113 Days for SAD; 0-143 Days for MAD

• Circulating half-life of ATTO-1310 (t1/2)

  0-113 Days for SAD; 0-143 Days for MAD

• Area Under the Plasma Concentration Versus Time Curve (AUC)

  0-113 Days for SAD; 0-143 Days for MAD

• Clearance rate (C) of ATTO-1310

  0-113 Days for SAD; 0-143 Days for MAD

Study Arms (6)

ATTO-1310 single dose IV

EXPERIMENTAL

ATTO-1310 Attobody Dose level cohorts receiving a single dose IV

Drug: ATTO-1310

ATTO-1310 Placebo single dose IV

PLACEBO COMPARATOR

Placebo preparation to match Experimental Arm with single dose IV

Drug: ATTO-1310 Placebo

ATTO-1310 single dose SC

EXPERIMENTAL

ATTO-1310 Attobody Dose level cohorts receiving a single dose SC

Drug: ATTO-1310

ATTO-1310 Placebo single dose SC

PLACEBO COMPARATOR

Placebo preparation to match Experimental Arm with single dose SC

Drug: ATTO-1310 Placebo

ATTO-1310 multiple dose SC

EXPERIMENTAL

ATTO-1310 Attobody administered to dose level cohorts in multiple SC doses

Drug: ATTO-1310

ATTO-1310 Placebo multiple dose SC

PLACEBO COMPARATOR

Placebo preparation to match Experimental Arm administered in multiple SC doses

Drug: ATTO-1310 Placebo

Interventions

ATTO-1310 DRUG

ATTO-1310 Attobody

ATTO-1310 multiple dose SC; ATTO-1310 single dose IV; ATTO-1310 single dose SC

ATTO-1310 Placebo DRUG

Placebo preparation to match ATTO-1310 Dose

ATTO-1310 Placebo multiple dose SC; ATTO-1310 Placebo single dose IV; ATTO-1310 Placebo single dose SC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attovia Therapeutics Inc: lead

Study Sites (17)

Attovia Clinical Site 103

Encinitas, California, 92024, United States

Location

Attovia Clinical Site 116

Rocklin, California, 95765, United States

Location

Attovia Clinical Site 107

Sacramento, California, 95815, United States

Location

Attovia Clinical Site 109

Coral Gables, Florida, 33134, United States

Location

Attovia Clinical Site 118

Margate, Florida, 33063, United States

Location

Attovia Clinical Site 102

Plainfield, Indiana, 46168, United States

Location

Attovia Clinical Site 104

Saint Joseph, Missouri, 64506, United States

Location

Attovia Clinical Site 106

Reno, Nevada, 89509, United States

Location

Attovia Clinical Site 114

New York, New York, 10029, United States

Location

Attovia Clinical Site 119

New York, New York, 10128, United States

Location

Attovia Clinical Site 108

San Antonio, Texas, 78213, United States

Location

Attovia Clinical Site 110

Fredericton, New Brunswick, E3B1G9, Canada

Location

Attovia Clinical Site 111

Newmarket, Ontario, L3Y 5G8, Canada

Location

Attovia Clinical Site 112

Peterborough, Ontario, K9J 5K2, Canada

Location

Attovia Clinical Site 113

Toronto, Ontario, M4W 2N4, Canada

Location

Attovia Clinical Site 105

Montreal, Quebec, H2X2V1, Canada

Location

Altasciences

Montreal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Sicard, MD

  Altasciences Company Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending dose, multiple ascending dose, randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 22, 2025
• Study Start: January 14, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6); US (11)