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.
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
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
Sequential
ATTO-1091
DrugATTO-1091
Placebo
DrugPlacebo preparation to match ATTO-1091 dose
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.
Incidence of laboratory abnormalities
Clinical laboratory parameters (hematologic and blood chemistry) will be summarized by visit
Incidence of ECG abnormalities
ECG findings (including QT abnormalities) will be summarized by visit.
Incidence of vital sign abnormalities
Vital signs (systolic and diastolic blood pressure, temperature, heart rate) will be summarized by visit.
Incidence of Anti-drug Antibodies
Baseline prevelance of ADA, changes in ADA status from prior to the first dose of IP to each applicable post-dose timepoint and ADA titer values for samples confirmed positive for ADA will be evaluated to assess the immunogenicity of single and multiple dose levels of ATT-1091.
Peak Plasma Concentration (Cmax) of ATTO-1091
The pharmacokinetics of single and multiple dose levels of ATTO-1091 in participants will include maximum concentration (Cmax) of ATTO-1091
Circulating Half-life (t1/2) of ATTO-1091
The pharmacokinetics of single and multiple dose levels of ATTO-1091 in participants will include half-life (t1/2) of ATTO-1091
Area Under the Plasma Concentration versus Time Curve (AUC) ATTO-1091
The pharmacokinetics of single and multiple dose levels of ATTO-1091 in participants will include area under the plasma concentration-time curve (AUC).
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