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An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)

NCT05084261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-08

No results posted yet for this study

Summary

This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3 ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be based on the safety and tolerability of the previous cohort.

Conditions

Interventions

DRUG

BT051 200 mg

Oral BT051 200 mg once daily for 28 days.

DRUG

BT051 800 mg

Oral BT051 800 mg once daily for 28 days.

DRUG

BT051 3200 mg

Oral BT051 3200 mg once daily for 28 days.

DRUG

Matching Placebo

Placebo Matching BT051

Sponsors & Collaborators

  • Adiso Therapeutics

    lead INDUSTRY

Principal Investigators

  • Renu Gupta, MD · Adiso Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-11-30
Completion
2022-11-30
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Moldova
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05084261 on ClinicalTrials.gov