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.
This is a 3-part study. Parts 1 and 2 will be a single and multiple ascending dose design, respectively, assessing the safety, tolerability, and PK of ATTO-1091 in healthy adult volunteers. Part 3 will consist of multiple doses in adult participants with ulcerative colitis to assess safety, tolerability, and PK.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
ATTO-1091
Placebo 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC
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.
Time frame: 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
The pharmacokinetics of single and multiple dose levels of ATTO-1091 in participants will include maximum concentration (Cmax) of ATTO-1091
Time frame: 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
The pharmacokinetics of single and multiple dose levels of ATTO-1091 in participants will include half-life (t1/2) of ATTO-1091
Time frame: 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
The pharmacokinetics of single and multiple dose levels of ATTO-1091 in participants will include area under the plasma concentration-time curve (AUC).
Time frame: 0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 for MAD in UC
Clearance Rate (C) for ATTO-1091
The pharmacokinetics of single and multiple dose levels of ATTO-1091 in participants will include characterization of the clearance rate (C) of ATTO-1091.
Time frame: 0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 for MAD in UC
Volume of Distribution (V) of ATTO-1091
The pharmacokinetics of single and multiple dose levels of ATTO-1091 in participants will include characterization of the Volume of distribution (V) of ATTO-1091.
Time frame: 0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC
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