GB004 in Adult Subjects With Active Ulcerative Colitis

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Disease, Ulcerative Colitis

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.

Detailed description

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.

Silvio Danese, Barrett G. Levesque, Brian G. Feagan, Alina Jucov, Bal Raj Bhandari et al. (16 authors)

Alimentary Pharmacology & Therapeutics2022-01-1030 citations

10.1111/apt.16753

P066 GB004, A NOVEL GUT-TARGETED PROLYL HYDROXYLASE INHIBITOR FOR INFLAMMATORY BOWEL DISEASE: FIRST-IN-HUMAN, MUTLIPLE-DOSE STUDY IN HEALTHY SUBJECTS WITH GUT BIOPSIES

Barrett G. Levesque, Kristen Taylor Meadows, Akshay Buch, Michael Flynn, Kevin S. Peters et al. (12 authors)

Inflammatory Bowel Diseases2020-01-015 citations

10.1093/ibd/zaa010.023

P540 GB004, a novel prolyl hydroxylase inhibitor for inflammatory bowel disease, leads to gut-targeted HIF-1α pathway engagement in a multiple-dose study in healthy subjects

Barrett G. Levesque, Kristen Taylor Meadows, Akshay Buch, Michael A. Flynn, Kevin G. Peters et al. (12 authors)

Journal of Crohn s and Colitis2020-01-012 citations

10.1093/ecco-jcc/jjz203.668

P034 GB004, a novel gut-targeted prolyl hydroxylase inhibitor, induces HIF-1α target genes and is efficacious in mouse colitis

Kristen Taylor Meadows, Michael J. Kennedy, Zachary Naiman, Masha Sergeeva, Bryanna Paulson et al. (9 authors)

Journal of Crohn s and Colitis2020-01-011 citations

10.1093/ecco-jcc/jjz203.163

P051 Phase 1a Safety and Pharmacokinetic Effects of GB004, a Novel Prolyl Hydroxylase Inhibitor and Potential Therapy for Inflammatory Bowel Disease

Barrett G. Levesque, Michael A. Flynn, Kevin G. Peters, Akshay Buch

The American Journal of Gastroenterology2019-12-013 citations

10.14309/01.ajg.0000613172.41188.d4

Interventions

DRUGGB004

GB0004 high dose

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment emergent adverse events	56 Days	To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.

Secondary

Measure	Time frame
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

Countries

Georgia, Moldova, United States

Outcome results

None listed