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ATTO-1091

Phase 1

Ulcerative Colitis (UC) | Small molecule | Other |Alamar Biosciences, Inc.|Last Updated: Sep 15, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

ATTO-1091 · 1 trial · 1 indication

Phase 1 1
NCT07819799Safety, Tolerability and PK of ATTO 1091 in Healthy Adult Volunteers and Patients With Ulcerative ColitisUlcerative Colitis (UC)
NOT YET_RECRUITING96 Analytics
PHASE1NOT YET_RECRUITING
Safety, Tolerability and PK of ATTO 1091 in Healthy Adult Volunteers and Patients With Ulcerative Colitis
Ulcerative Colitis (UC)Unlock trial analytics

Study Endpoints

Primary Endpoints

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

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

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

Incidence of ECG abnormalities
0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC

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

Incidence of vital sign abnormalities
0-169 Days for SAD; 0-204 Days for MAD in HV; 0-141 Days for MAD in UC

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ATTO-1091 Single dose SCEXPERIMENTALATTO-1091 Dose level cohorts receiving a single dose SC
ATTO-1091 Multiple dose SCEXPERIMENTALATTO-1091 Dose level cohorts receiving multiple SC doses
Placebo single dose SCEXPERIMENTALPlacebo preparation to match Experimental Arm with single dose SC
Placebo multiple dose SCEXPERIMENTALPlacebo preparation to match Experimental Arm administered in multiple SC doses

Interventions

NameTypeDescription
ATTO-1091DRUGATTO-1091
PlaceboDRUGPlacebo preparation to match ATTO-1091 dose
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes

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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Recent Changes (Last 90 Days)

LOWSep 16, 2026NCT07819799NEW_TRIAL: changed
LOWSep 16, 2026NCT07819799NEW_TRIAL: changed