GB004 in Adult Subjects With Active Ulcerative Colitis
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
1 other identifier
interventional
34
3 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2019
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedStudy Start
First participant enrolled
April 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2019
CompletedJanuary 14, 2020
January 1, 2020
8 months
February 14, 2019
January 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment emergent adverse events
To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.
56 Days
Secondary Outcomes (3)
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004
Day 1 to Day 28
Pharmacokinetics: Maximum Concentration (Cmax) of GB004
Day 1 to Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004
Day 1 to Day 28
Study Arms (2)
GB004
EXPERIMENTALGB004 for oral administration daily
Placebo
PLACEBO COMPARATORPlacebo for oral administration daily
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.
You may not qualify if:
- Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
- Patients receiving biologic agents and experimental agents are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Delta Research Partners
Monroe, Louisiana, 71201, United States
Arensia Exploratory Medicine
Tbilisi, 0112, Georgia
PMSI Republican Clinical Hospital "Timofei Mosneaga"
Chisinau, MD2025, Moldova
Related Publications (1)
Danese S, Levesque BG, Feagan BG, Jucov A, Bhandari BR, Pai RK, Taylor Meadows K, Kirby BJ, Bruey JM, Olson A, Osterhout R, Van Biene C, Ford J, Aranda R, Raghupathi K, Sandborn WJ. Randomised clinical trial: a phase 1b study of GB004, an oral HIF-1alpha stabiliser, for treatment of ulcerative colitis. Aliment Pharmacol Ther. 2022 Feb;55(4):401-411. doi: 10.1111/apt.16753. Epub 2022 Jan 10.
PMID: 35014040DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2019
First Posted
March 4, 2019
Study Start
April 24, 2019
Primary Completion
December 17, 2019
Study Completion
December 17, 2019
Last Updated
January 14, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share