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 - 75 Years|
- - Be male or female, ≥18 and ≤75 years of age.
- - Be willing to give informed consent.
- - Have a body mass index ≥18.5 and <45 kg/m2.
- - Confirmed diagnosis of UC (>6 months) by endoscopy.
- - Mild-to-moderate UC with at least 4 weeks of UC symptoms prior to screening.
- - Stable dose of oral mesalamine or purine analogs for at least 4 weeks prior to screening.
- - Be willing to maintain a stable diet and continue taking the same regimen of supplements for the duration of the study.
- - Female patients who are not pregnant and not trying to become pregnant or lactating.
- - Possible or confirmed diagnosis of Crohn's disease.
- - Prior medical history of isolated distal proctitis limited to the rectum due to IBD or other etiologies.
- - Use of any antidiarrheal medications within the last 1 week prior to screening.
- - Antibiotic treatment within the past 28 days prior to screening.
- - Certain prior UC treatments (including biologics) as described in the protocol.
- - Any immunosuppressive medications other than purine analog and no systemic corticosteroids.
- - Major intra-abdominal surgery related to the bowel within 24 weeks prior to the screening period and/or planned invasive surgery/hospitalization during the study.
- - Major medical comorbidities, or other conditions in the opinion of the PI, that might impact the patient's safety or compliance, or the interpretation of the study results.
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.
|Mark Wingertzahn, PhD|
|Principal Investigator Affiliation||Kaleido Biosciences|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Ireland, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Other: - KB295
KB295 is a novel glycan
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.