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GB004 in Adult Subjects With Active Ulcerative Colitis

NCT03860896 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-01-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

GB004

GB0004 high dose

DRUG

Placebo

Placebo

DRUG

GB004

GB004 low dose

Sponsors & Collaborators

  • GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2019-12-17
Completion
2019-12-17
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Moldova

Study Locations

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Entities

Drugs
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 NCT03860896 on ClinicalTrials.gov