Safety, Tolerability and PK of ATTO 1091 in Healthy Adult Volunteers and Patients With Ulcerative Colitis

NCT07819799 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ATTO-1091-101
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics (PK) of ATTO-1091 in healthy adults and patients with ulcerative colitis. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-1091? How long does ATTO-1091 stay in the body after dosing? Researchers will compare ATTO-1091 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1091 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.

Conditions

Ulcerative Colitis (UC)

Keywords

ulcertive colitis; IBD; UC

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.

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC

• Incidence of laboratory abnormalities

  Clinical laboratory parameters (hematologic and blood chemistry) will be summarized by visit

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC

• Incidence of ECG abnormalities

  ECG findings (including QT abnormalities) will be summarized by visit.

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC

• Incidence of vital sign abnormalities

  Vital signs (systolic and diastolic blood pressure, temperature, heart rate) will be summarized by visit.

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC

Secondary Outcomes (6)

• Incidence of Anti-drug Antibodies

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC

• Peak Plasma Concentration (Cmax) of ATTO-1091

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC

• Circulating Half-life (t1/2) of ATTO-1091

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 for MAD in UC

• Area Under the Plasma Concentration versus Time Curve (AUC) ATTO-1091

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 for MAD in UC

• Clearance Rate (C) for ATTO-1091

  0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 for MAD in UC

Study Arms (4)

ATTO-1091 Single dose SC

EXPERIMENTAL

ATTO-1091 Dose level cohorts receiving a single dose SC

Drug: ATTO-1091

ATTO-1091 Multiple dose SC

EXPERIMENTAL

ATTO-1091 Dose level cohorts receiving multiple SC doses

Drug: ATTO-1091

Placebo single dose SC

EXPERIMENTAL

Placebo preparation to match Experimental Arm with single dose SC

Drug: Placebo

Placebo multiple dose SC

EXPERIMENTAL

Placebo preparation to match Experimental Arm administered in multiple SC doses

Drug: Placebo

Interventions

ATTO-1091 DRUG

ATTO-1091

ATTO-1091 Multiple dose SC; ATTO-1091 Single dose SC

Placebo DRUG

Placebo preparation to match ATTO-1091 dose

Placebo multiple dose SC; 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 60 years old, inclusive, at Screening.
• Body weight of 45 to 125 kg, inclusive, 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.
• Meets contraception requirements
• Negative pregnancy test for participants of childbearing potential.
• Any sex or gender who is 18 to 80 years old
• Body weight of 45 to 125 kg and BMI between 17.0 and 40.0 kg/m2
• UC diagnosis confirmed by endoscopy and histology ≥3 months prior to Screening
• Moderately to severely active UC as defined by Modified Mayo Clinic Score (stool frequency, rectal bleeding, endoscopy) 5 to 9 inclusive, with Mayo endoscopic subscore ≥2 as confirmed by the central reader during Screening
• Rectal bleeding subscore ≥1 and stool frequency subscore ≥1 at Screening.
• Naïve to treatment with advanced therapies or has had an inadequate response, loss of response, or intolerance to no more than 3 drugs in 2 classes of the following:
• Tumor necrosis factor (TNF-α) antagonists
• Interleukin IL-12/IL-23 antagonists
• Integrin inhibitors
• JAK antagonists

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 systemic corticosteroids or hospitalization for asthma within 6 months prior to Day 1
• History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients
• 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 to approximately 40 mg nicotine) per day
• History of drug or alcohol abuse
• Laboratory values outside of the normal range considered clinically significant by the investigator
• 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 systemic corticosteroids or hospitalization for asthma within 6 months prior to Day 1
• History of known primary immunodeficiency or is considered immunocompromised

Sponsors & Collaborators

• Attovia Therapeutics Inc: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Hubert Chen, MD

  Attovia Therapeutics Inc

  STUDY DIRECTOR

Central Study Contacts

Malinda Longphre

CONTACT

15105203361; mlongphre@attovia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 (SAD) and Part 2 (MAD) in HV will be fully blinded and placebo controlled. Part 3 (MAD) in participants with ulcerative colitis will be open-label active treatment only.
• 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 9, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): December 14, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09