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NCT Number: NCT03860896

GB004 in Adult Subjects With Active Ulcerative Colitis

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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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arensia Exploratory Medicine, Tbilisi, Georgia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GB004

Drug

GB0004 high dose

Placebo

Drug

Placebo

Primary outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: 56 Days

    To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.

Secondary outcomes

  1. Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004

    Time frame: Day 1 to Day 28

  2. Pharmacokinetics: Maximum Concentration (Cmax) of GB004

    Time frame: Day 1 to Day 28

  3. Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004

    Time frame: Day 1 to Day 28

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2019
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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