Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis

NCT07205081 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ATTO-3712-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Volunteers; Atopic Dermatitis (AD); Atopic Eczema; Atopic Eczema/Dermatitis (Non-Specific)

Keywords

Atopic Dermatitis; AD; Atopic Eczema; Ecema; 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 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

Secondary Outcomes (7)

• Incidence of Anti-Drug Antibodies

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

• Peak plasma concentration (Cmax) ATTO-3712

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

• Circulating half-life of ATTO-3712 (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-3712

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

Study Arms (6)

ATTO-3712 single dose IV

EXPERIMENTAL

ATTO-3712 Dose level cohorts receiving a single dose IV

Drug: ATTO-3712

Placebo single dose IV

PLACEBO COMPARATOR

Placebo preparation to match Experimental Arm with single dose IV

Drug: Placebo

ATTO-3712 single dose SC

EXPERIMENTAL

ATTO-3712 dose level cohorts receiving a single dose SC

Drug: ATTO-3712

Placebo single dose SC

PLACEBO COMPARATOR

Placebo preparation to match Experimental Arm with single dose SC

Drug: Placebo

ATTO-3712 multiple dose SC

EXPERIMENTAL

ATTO-3712 administered to dose level cohorts in multiple SC doses

Drug: ATTO-3712

Placebo multiple dose SC

PLACEBO COMPARATOR

Placebo preparation to match Experimental Arm administered in multiple SC doses

Drug: Placebo

Interventions

ATTO-3712 DRUG

ATTO-3712

ATTO-3712 multiple dose SC; ATTO-3712 single dose IV; ATTO-3712 single dose SC

Placebo DRUG

Placebo preparation to match ATTO-3712 dose

Placebo multiple dose SC; Placebo single dose IV; Placebo single dose SC

Eligibility Criteria

• Age: 18 Years - 65 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, 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.
• 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

You may not qualify if:

• 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
• Any clinically significant underlying illness
• Presence of skin comorbidities that may interfere with study assessments
• Has taken prescription medication for the treatment of AD or other prohibited medication within the restricted time limits (defined in the protocol)
• Has applied topical corticosteroids within 2 weeks prior to dosing.
• History of malignancy within 5 years of Screening

Sponsors & Collaborators

• Attovia Therapeutics Inc: lead

Study Sites (1)

Altasciences

Montreal, Quebec, H3P 3P1, Canada

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 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

Central Study Contacts

Malinda Longphre, PhD

CONTACT

+1 510-520-3361; ATTO-3712-101Clinical@attovia.com

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: September 24, 2025
• First Posted: October 3, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)