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ATTO-1091 · 1 trial · 1 indication
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.
Clinical laboratory parameters (hematologic and blood chemistry) will be summarized by visit
ECG findings (including QT abnormalities) will be summarized by visit.
Vital signs (systolic and diastolic blood pressure, temperature, heart rate) will be summarized by visit.
| Arm | Type | Description |
|---|---|---|
| ATTO-1091 Single dose SC | EXPERIMENTAL | ATTO-1091 Dose level cohorts receiving a single dose SC |
| ATTO-1091 Multiple dose SC | EXPERIMENTAL | ATTO-1091 Dose level cohorts receiving multiple SC doses |
| Placebo single dose SC | EXPERIMENTAL | Placebo preparation to match Experimental Arm with single dose SC |
| Placebo multiple dose SC | EXPERIMENTAL | Placebo preparation to match Experimental Arm administered in multiple SC doses |
| Name | Type | Description |
|---|---|---|
| ATTO-1091 | DRUG | ATTO-1091 |
| Placebo | DRUG | Placebo preparation to match ATTO-1091 dose |
Parts 1\&2 (Healthy Volunteers) Key Inclusion Criteria: * 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,...
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ATTO-1091 is an investigational small molecule being developed for the treatment of ulcerative colitis (UC), a form of inflammatory bowel disease. It is not yet approved for any indication and remains in clinical development, with a Phase 1 program evaluating its safety, tolerability, and pharmacokinetics in healthy adult volunteers and patients with ulcerative colitis.
ATTO-1091 is being developed by Alamar Biosciences, Inc., which trades under the ticker ALMR. The company is the sponsor of the Phase 1 clinical program for the candidate in ulcerative colitis.
ATTO-1091 is in Phase 1 clinical development. The program consists of a single Phase 1 trial that is currently active but not yet recruiting, with a planned enrollment of 96 participants. The drug is investigational and has not been approved for marketing in any indication.
ATTO-1091 is being studied in one Phase 1 trial, NCT07819799, titled "Safety, Tolerability and PK of ATTO 1091 in Healthy Adult Volunteers and Patients With Ulcerative Colitis." The trial is randomized, double-blind, and controlled, with a planned enrollment of 96 participants aged 18 years and older, including healthy volunteers.
No. ATTO-1091 is an investigational small molecule in Phase 1 clinical development for ulcerative colitis and has not been approved by the FDA or any other regulatory agency. Its safety and efficacy are still being evaluated in the ongoing Phase 1 trial NCT07819799.