Clinical trials: Inflammatory Bowel System
- Condition Inflammatory Bowel System
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Ulcerative Colitis
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately…
- Trial name
- NCT00269438
- Testing
- 5 ASA, enemas, suppositories, corticosteroids
- Where
- 66 sites in United States
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Healthy
Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600.
- Trial name
- NCT02309827
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Pfizer
MASH, PSC
A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer [68Ga]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers…
- Conditions
- MASH, PSC, Fibrostenotic Crohn's Disease, Healthy Volunteers
- Trial name
- NCT06562361
- Testing
- [68Ga]Ga-DOTA-Cys-ATH001
- Where
- 3 sites in Sweden
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Antaros Medical
Ulcerative Colitis
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.
- Trial name
- NCT06627556
- Testing
- H021
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Jiangsu Carephar Pharmaceutical Co., Ltd.
Inflammatory Bowel Diseases, Irritable Bowel Syndrome
ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation.
- Trial name
- NCT03082287
- Testing
- Fecal Calprotectin Level
- Where
- United States
- Volunteers
- 424 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Insulin Resistance
Impact of Starch Digestibility on Glycemic Variability and Control, Cardiometabolic and Inflammatory Profiles, Microbiota and Intestinal Health in Subjects With Insulin Resistance
To study the potential impact of a diet rich in both Slowly Digestible Starch (SDS) and Resistant Starch (RS), we propose a 2-month nutritional intervention study in which we will study the evolution of carbohydrate variability…
- Trial name
- GLYMICARE (NCT07408479)
- Testing
- Balanced diet high in Slowly Digestible Starch and Resistant Starch, Balanced diet low in Slowly Digestible Starch and Resistant Starch
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Ulcerative Colitis
PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated.
- Trial name
- PROREM UC (NCT03415711)
- Testing
- VSL#3®, Mesalamine
- Where
- Italy
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- VSL Pharmaceuticals
Ulcerative Colitis, Crohn Disease
HMPL004-6599 Phase I Dose-escalating Study
To assess the safety and tolerability of single and multiple doses of HMPL004-6599 in healthy male volunteers
- Trial name
- NCT03597971
- Testing
- HMPL004-6599
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nutrition Science Partners Limited
Crohn's Disease
Bologna IBD Markers
Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.
- Trial name
- NCT02580864
- Where
- Italy
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Inflammatory Bowel Disease (IBD)
A Phase 1 Study of PVT401 in Healthy Subjects
The goal of this clinical trial is to learn what happens to PVT401 when it enters the human body and how it affects the immune system.
- Trial name
- NCT07423000
- Testing
- PVT401, Normal Saline (0.9% NaCl)
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Parvus Therapeutics, Inc.
Inflammatory Bowel Disease (IBD)
Phase I Study of QLS1510 Tablets in Healthy Participants
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
- Trial name
- NCT07760077
- Testing
- QLS1510 Tablets
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
Healthy Volunteers, Ulcerative Colitis
Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects.
- Trial name
- NCT02864264
- Testing
- BMS-986184
- Where
- 3 sites in Australia, Georgia and 1 more
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Colitis, Ulcerative, Crohn's Disease
OTIS Vedolizumab Pregnancy Exposure Registry
The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to…
- Trial name
- NCT02678052
- Testing
- Vedolizumab, Other Biological Agent
- Where
- United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Takeda
Ulcerative Colitis (UC), Healthy Volunteer
Phase 1 Study Evaluating PALI-2108 in Healthy Volunteers and Ulcerative Colitis Patients.
PALI-2108 is a new oral medication designed to treat ulcerative colitis (UC) by targeting the intestines. It works as a phosphodiesterase-4 (PDE4) inhibitor prodrug, meaning it becomes active only after being processed by…
- Trial name
- NCT06663605
- Testing
- PALI-2108
- Where
- Canada
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Palisade Bio
Coronary Artery Disease, Congestive Heart Failure
Prognostic Indicators as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known…
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation
- Trial name
- GBMC (NCT01476995)
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Ulcerative Colitis
Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions
The objective of this study was to assess bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single…
- Trial name
- NCT00618228
- Testing
- Balsalazide
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Inflammatory Bowel Disease
Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab
The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo.
- Trial name
- NCT01981616
- Testing
- Vedolizumab, Hepatitis B vaccine, Oral cholera vaccine
- Where
- United Kingdom
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Ulcerative Colitis
TP0502-B-Pharmaco-Scintigraphic-Study
This is a Phase I, open-label, single-site trial to evaluate the drug release, using scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9] subjects will be evaluated.
- Trial name
- NCT02306798
- Testing
- TP05
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Tillotts Pharma AG
Colitis, Ulcerative
Single Dose Study of Tulisokibart (MK-7240) in Healthy Chinese Participants (MK-7240-002)
The goal of this study is to learn about the safety of tulisokibart in healthy participants and what happens to tulisokibart over time when participants receive treatment intravenously versus subcutaneously.
- Trial name
- NCT06829225
- Testing
- Tulisokibart
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC