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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• 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

• 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

⁃ Parts 1 \& 2 (Healthy Volunteers) Exclusion Criteria:

• 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

Locations
United States
California
Attovia Clinical Site 103
RECRUITING
Encinitas
Attovia Clinical Site 116
RECRUITING
Rocklin
Attovia Clinical Site 107
RECRUITING
Sacramento
Florida
Attovia Clinical Site 109
RECRUITING
Coral Gables
Indiana
Attovia Clinical Site 102
RECRUITING
Plainfield
Missouri
Attovia Clinical Site 104
RECRUITING
Saint Joseph
Nevada
Attovia Clinical Site 106
RECRUITING
Reno
New York
Attovia Clinical Site 114
RECRUITING
New York
Texas
Attovia Clinical Site 108
RECRUITING
San Antonio
Other Locations
Canada
Attovia Clinical Site 110
RECRUITING
Fredericton
Altasciences
ACTIVE_NOT_RECRUITING
Montreal
Attovia Clinical Site 105
RECRUITING
Montreal
Attovia Clinical Site 111
RECRUITING
Newmarket
Attovia Clinical Site 112
RECRUITING
Peterborough
Attovia Clinical Site 113
RECRUITING
Toronto
Contact Information
Primary
Malinda Longphre, PhD
ATTO-1310-101Clinical@attovia.com
+1 510-520-3361
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2026-05
Participants
Target number of participants: 104
Treatments
Experimental: ATTO-1310 single dose IV
ATTO-1310 Attobody Dose level cohorts receiving a single dose IV
Placebo_comparator: ATTO-1310 Placebo single dose IV
Placebo preparation to match Experimental Arm with single dose IV
Experimental: ATTO-1310 single dose SC
ATTO-1310 Attobody Dose level cohorts receiving a single dose SC
Placebo_comparator: ATTO-1310 Placebo single dose SC
Placebo preparation to match Experimental Arm with single dose SC
Experimental: ATTO-1310 multiple dose SC
ATTO-1310 Attobody administered to dose level cohorts in multiple SC doses
Placebo_comparator: ATTO-1310 Placebo multiple dose SC
Placebo preparation to match Experimental Arm administered in multiple SC doses
Related Therapeutic Areas
Sponsors
Leads: Attovia Therapeutics Inc

This content was sourced from clinicaltrials.gov

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