GB004 in Adult Subjects With Active Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2019-12-17

Brief Summary

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This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed.

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Detailed Description

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The safety, tolerability, pharmacokinetics, and pharmacodynamics of GB004 will be explored in a Phase 1b randomized controlled trial in adults subjects with active ulcerative colitis (UC). Subjects will be evaluated based on incidence of AEs, laboratory parameters, GB004 serum and colonic tissue concentrations, and changes in the signs and symptoms of UC.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GB004

GB004 for oral administration daily

Group Type EXPERIMENTAL

GB004

Intervention Type DRUG

GB0004 high dose

GB004

Intervention Type DRUG

GB004 low dose

Placebo

Placebo for oral administration daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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GB004

GB0004 high dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

GB004

GB004 low dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.

Exclusion Criteria

* Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
* Patients receiving biologic agents and experimental agents are excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No