Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
- - UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.
- - Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments: 1.
- - Prior approved biologic therapy used for the treatment of UC.
- - Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
- - Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
- - Azathioprine, or 6-mercaptopurine within 1 day of Day 1.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Barrett Levesque, MD|
|Principal Investigator Affiliation||Gossamer Bio Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Georgia, Korea, Republic of, Moldova, Republic of, Poland, Russian Federation, Serbia, Ukraine, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: GB004 Dose A
GB004 dose A for oral administration for 36 weeks
Experimental: GB004 Dose B
GB004 dose B for oral administration for 36 weeks
Placebo Comparator: Placebo
Placebo for oral administration for 36 weeks
Experimental: Open-Label GB004 Dose A
GB004 dose A for oral administration for 24 weeks
Drug: - GB004
GB004, a small molecule hypoxia inducible factor 1 alpha (HIF-1α) stabilizer
Drug: - Placebo
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.