Clinical trials: Crohn's
Healthy
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses…
- Trial name
- NCT06715540
- Testing
- BCD-261, dose 1, BCD-261, dose 2, BCD-261, dose 3
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biocad
Ulcerative Colitis, Crohn's Disease
Threonine Requirement in IBD Adults and Healthy Adult Controls
The daily requirement of threonine, an essential amino acid, will be evaluated in healthy adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator amino acid oxidation (IAAO) method.
- Conditions
- Ulcerative Colitis, Crohn's Disease, Healthy
- Trial name
- NCT02423460
- Testing
- Threonine
- Where
- Canada
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
This is a randomized, double-blind, placebo-parallel controlled phase I study to evaluate the safety and tolerability of single and multiple doses of CM551 in healthy participants
- Trial name
- NCT07900945
- Testing
- CM551
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Keymed Biosciences Co.Ltd
Inflammatory Bowel Diseases
ImmuneSense™ IBD Study
This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase.
- Trial name
- NCT05769829
- Where
- 6 sites in United States
- Volunteers
- 484 people, healthy volunteers welcome
- Sponsor
- Adaptive Biotechnologies
Ulcerative Colitis, Crohn's Disease
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A.
- Trial name
- NCT02749630
- Testing
- UTTR1147A
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy Subjects, Crohns Disease
AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease
This study will assess the safety, tolerability, immunogenicity, and pharmacokinetics (PK), and explore the pharmacodynamics (PD) following single ascending dose administration and repeat dose administration in healthy subjects…
- Trial name
- NCT05452304
- Testing
- AZD7798
- Where
- United Kingdom
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Crohn Disease
Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
The objectives of the study are to evaluate the safety and tolerability of oral administration of MB-102, and to evaluate the use of MB-102 as a means of measuring gut permeability in normal participants (n=10) and in those with…
- Trial name
- NCT03962998
- Testing
- Lactulose/Rhamnose solution, MB-102
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Crohn's Disease
A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects
The purpose of this study is to test the effects of study drug (GSK1605786) on the blood levels of multiple commonly used drugs that are given to measure how your liver breaks down the study drug.
- Trial name
- NCT01489943
- Testing
- GSK1605786 500 mg, Midazolam 3 mg, Pioglitazone 15 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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)
Crohn's Disease
Japanese Phase I of GSK1605786
This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A.
- Trial name
- NCT01611805
- Testing
- GSK1605786
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Crohn's Disease
PBMC (Peripheral Blood Mononuclear Cells) /Lymphocyte SPECT (Single Photon Emission Computerized Tomography) Imaging in Crohn's Disease
Using scintigraphic imaging including planar scintigraphy and SPECT, this study will evaluate the utility of two different ex vivo 99mTc-HMPAO labelled mononuclear cell populations in order to select the optimal methodology…
- Trial name
- NCT01051622
- Testing
- Labeling Ceretec
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Crohn's Disease
Positron Emission Tomography (PET) Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
The purpose of this study is to measure the changes in small bowel uptake of radioligand [11^C]AZ14132516 after intravenous (IV) administration of single and repeat doses of AZD7798 in healthy participants and participants with…
- Trial name
- NCT06053424
- Testing
- AZD7798, [11C]AZ14132516
- Where
- Sweden
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Fibrostenotic Crohn's Disease
Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
This is an open, two-part study in healthy male volunteers, aged 30-65 years. This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of…
- Trial name
- NCT07672574
- Testing
- Ontunisertib, [14C]ontunisertib
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Agomab Spain S.L.U.
Crohn Disease
Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease
This study will evaluate the safety of oral administration of EcoActive to patients with inactive Crohn's disease and how it affects the levels of AIEC in stool.
- Trial name
- NCT03808103
- Testing
- Bacteriophage preparation
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Intralytix, Inc.
Ulcerative Colitis, Crohn's Disease
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.
To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
- Trial name
- NCT01290042
- Testing
- AMG 181
- Where
- 8 sites in United States, Australia
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Amgen
Crohn's Disease
A First Time in Human Study in Healthy Volunteers and Patients
A multi-part study to investigate the safety, tolerability and local and systemic pharmacokinetics of V565
- Trial name
- NCT03010787
- Testing
- V565
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- VHsquared Ltd.
Ulcerative Colitis (UC), Ulcerative Colitis (Disorder)
A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult
A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in…
- Conditions
- Ulcerative Colitis (UC), Ulcerative Colitis (Disorder), Ulcerative Colitis Acute, IBD (Inflammatory Bowel Disease)
- Trial name
- NCT07632573
- Testing
- BDHK-2009 Tablets
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Benethera (Shaoxing) Biotechnology Co., Ltd.
Crohn's Disease
Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)
This study will be conducted in healthy male or female subjects using a double-blind, randomized, placebo-controlled, single-dose design.
- Trial name
- NCT00950105
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
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
Moderate-to-severe Inflammatory Bowel Disease
A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with…
- Trial name
- NCT07758101
- Testing
- SHR-7590
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd