BT051 200 mg for Colitis (SCOUT Trial)

Phase 1

Waitlist Available

Research Sponsored by Adiso Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to days 14 and 28

Summary

This trial tests a new medication called BT051 for people with moderate to severe ulcerative colitis. The goal is to see if it is safe and can help reduce gut inflammation and symptoms. Participants will take the medication daily in different doses for about a month.

Eligible Conditions

Colitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to days 14 and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to days 14 and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to days 14 and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects experiencing treatment-emergent adverse events (TEAEs)

Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects observed with a change from baseline in physical examinations, clinical laboratory tests, vital signs, and electrocardiograms (ECG)

Secondary study objectives

Change in Mayo endoscopic, stool frequency, and rectal bleeding subscores.

Change in Robarts histopathology index (RHI) score

Change in UC-100 score

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Other study objectives

Area Under the Concentration-Time Curve (AUC) in whole blood

BT051 and BT070 concentrations in stool, colonic tissue, and urine

Maximum observed concentration (Cmax) in whole blood

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