Cure8 trial brief
This trial represents an early-stage clinical test of a new investigational drug (ATTO-1091) for people with ulcerative colitis; Phase 1 studies establish initial safety and how the drug behaves in the body, which are necessary steps before larger efficacy trials.
Adults with moderately to severely active ulcerative colitis (treatment-naïve or with limited prior advanced therapy exposure), clinicians and researchers involved in IBD drug development, and patients interested in participating in early-phase trials.
This is a Phase 1 interventional trial (not yet recruiting) testing ATTO-1091 given subcutaneously in healthy adults and in adults with moderately to severely active ulcerative colitis.
The study is designed in three parts: single-ascending dose and multiple-ascending dose in healthy volunteers, and a multiple-dose cohort in participants with UC, with primary outcomes focused on safety, tolerability, and pharmacokinetics compared to placebo.
The trial plans to enroll up to 96 participants and will monitor adverse events, laboratory and ECG changes, and vital signs across defined time windows.
Eligibility for the UC cohort requires endoscopy/histology-confirmed disease and a Modified Mayo Clinic Score consistent with moderate to severe activity; participants may be treatment-naïve or have had inadequate response/intolerance to a limited number of advanced therapies.
If you are considering trial participation, note this is an early first-in-human/first-in-patient trial primarily measuring safety and drug levels rather than efficacy.
Practical details such as dosing schedule, visit frequency, and specific exclusion criteria (active infections, prior malignancy, immunodeficiency, etc.) are specified in the full registry record.
This is a Phase 1 safety and PK study (NOT_YET_RECRUITING) registered on ClinicalTrials.gov and does not report any results. Phase 1 trials focus on safety and dosing and are not designed to demonstrate effectiveness. The registry entry contains full eligibility criteria and study procedures for prospective participants and clinicians.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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