Clinical trials: Human Gastrointestinal Tract
Focus of the Study is on Gut Health
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods.
- Trial name
- NCT01518088
- Testing
- Dietary Fiber
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ingredion Incorporated
Cystic Fibrosis
A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis
The Sponsor is developing KB407, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human Cystic Fibrosis Transmembrane Conductance Regulator…
- Trial name
- NCT05095246
- Testing
- KB407 (Nebulization)
- Where
- Australia
- Sponsor
- Krystal Biotech, Inc.
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Relapsed Malignant Solid Neoplasm
A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
- Trial name
- NCT05865002
- Testing
- AUR107
- Where
- 37 sites in India
- Volunteers
- 50 people
- Sponsor
- Aurigene Discovery Technologies Limited
Emphysema, Alpha 1-antitrypsin Deficiency (AATD)
Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor [alpha1-PI] [Human]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with…
- Trial name
- SPARK (NCT01213043)
- Testing
- Prolastin-C, 60 mg/kg, Prolastin-C, 120 mg/kg
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Grifols Therapeutics LLC
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.
Solid Tumor
A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
This is a Phase I, FIH, open-label, multi-site, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6…
- Trial name
- NCT04503278
- Testing
- CLDN6 CAR-T, CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
- Where
- 12 sites in Australia, Germany and 2 more
- Volunteers
- 214 people
- Sponsor
- BioNTech Cell & Gene Therapies GmbH
Advanced Solid Tumor, Non Small Cell Lung Cancer
A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors
Part 1: A first-in-human, open-label, Phase I dose escalation study of DSP107 monotherapy and combination therapy with atezolizumab in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer, Colorectal Cancer
- Trial name
- NCT04440735
- Testing
- DSP107, Atezolizumab
- Where
- 7 sites in United States
- Volunteers
- 125 people
- Sponsor
- Kahr Medical
Diphtheria, Pertussis
Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B).
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B
- Trial name
- NCT01362517
- Testing
- Quinvaxem
- Where
- Vietnam
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Renal Cell Carcinoma, Gastric Cancer
A Study of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD)
Study HC-404-FCP-2011 is a first in human, Phase 1a, multi-center, open-label study to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of oral dosing of HC-5404-FU in a dose-escalating fashion.
- Conditions
- Renal Cell Carcinoma, Gastric Cancer, Metastatic Breast Cancer, Small-cell Lung Cancer
- Trial name
- NCT04834778
- Testing
- HC-5404-FU
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- HiberCell, Inc.
Alpha-1 Antitrypsin Deficiency (AATD)
A Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CTX460 in Adults With Emphysema Associated With Severe Alpha-1 Antitrypsin Deficiency (AATD)
A Study of CTX460 in Adults with Emphysema Associated with Severe Alpha-1 Antitrypsin Deficiency (AATD).
- Trial name
- NCT07850076
- Testing
- CTX460
- Volunteers
- 68 people
- Sponsor
- CRISPR Therapeutics
Cystic Fibrosis
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.
- Trial name
- NCT01347190
- Testing
- CR002 Liquid API
- Where
- 11 sites in Bulgaria, Hungary and 2 more
- Volunteers
- 25 people
- Sponsor
- CSL Behring
Hepatitis B, Chronic Hepatitis B Atypical
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection
- Trial name
- NCT02981602
- Testing
- IONIS-HBVRx
- Where
- 7 sites in Hong Kong, South Korea
- Volunteers
- 31 people
- Sponsor
- GlaxoSmithKline
Alpha1-Antitrypsin Deficiency
Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency
This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous infusions of 60 mg/kg of Alpha-1 MP (alpha1-proteinase inhibitor (human), modified process) for 8 weeks.
- Trial name
- NCT02870309
- Testing
- Alpha-1 MP
- Where
- 2 sites in Japan
- Volunteers
- 4 people
- Sponsor
- Grifols Therapeutics LLC
Anxiety, Microbiome
Microbiome, Anxiety and Cognitive Orientation Study
Mounting evidence shows that the gut microbiome plays an important role in communication within the gut-brain axis. However, the relationship between gut microbiota and their influence on anxiety is still not fully understood.
- Conditions
- Anxiety, Microbiome, Mood Disorders, Neurodegeneration
- Trial name
- MACO (NCT05388630)
- Where
- United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Endominance
Acute Diarrhea
Human Milk Oligosaccharides and Childhood Diarrhoea
Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients hospitalized with acute diarrhoea.
- Trial name
- NCT02896465
- Testing
- Oral rehydration solution, Zinc, Human milk oligosaccharides
- Where
- Bangladesh
- Volunteers
- 435 people
- Sponsor
- Société des Produits Nestlé (SPN)
Viral Hepatitis Vaccines, Hepatitis A
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.
- Conditions
- Viral Hepatitis Vaccines, Hepatitis A, Cytomegalovirus, Varicella-Zoster Virus
- Trial name
- NCT01160081
- Testing
- Serum sample
- Where
- Mexico
- Volunteers
- 3,658 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lung Cancer, Lung Infection
Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath
The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) marker molecules.
- Conditions
- Lung Cancer, Lung Infection, COPD, Bronchitis
- Trial name
- NCT06528418
- Testing
- Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system
- Where
- China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- ChromX Health
Solid Tumor, Adult, Colorectal Cancer
Study of IK-595 in RAS- or RAF-altered Advanced Tumors
This is a Phase 1, FIH, Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue…
- Conditions
- Solid Tumor, Adult, Colorectal Cancer, Pancreatic Cancer, Malignant Melanoma
- Trial name
- NCT06270082
- Testing
- IK-595
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Ikena Oncology
Solid Tumor, NSCLC
SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
This is a first-in-human, multicenter, open-label Phase 1/2 study designed to evaluate the safety, efficacy, and tolerability of [225Ac]Ac-FL-261, a targeted radioligand therapy directed at c-MET, in participants with advanced or…
- Conditions
- Solid Tumor, NSCLC, Colorectal Cancer, Head and Neck Cancer
- Trial name
- NCT07873450
- Testing
- [225Ac]Ac-FL-261
- Where
- 2 sites in United States, Australia
- Volunteers
- 208 people
- Sponsor
- Full-Life Technologies UK Limited