Clinical trials: Gastrointestinal Tract
Cystic Fibrosis
Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects
This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.
- Trial name
- NCT01953367
- Testing
- Vantobra (tobramycin), TOBI (tobramycin)
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pari Pharma GmbH
Cystic Fibrosis, Pulmonary
Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single doses of ARO-ENaC in healthy adult volunteers; and to evaluate the safety, tolerability, PK and efficacy of multiple doses of…
- Trial name
- NCT04375514
- Testing
- ARO-ENaC
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors.
- Conditions
- Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck, HER2 Negative Breast Neoplasms, Esophageal Squamous Cell Carcinoma
- Trial name
- NCT04389632
- Testing
- sigvotatug vedotin, pembrolizumab, cisplatin
- Where
- 158 sites in United States, France and 5 more
- Volunteers
- 1,006 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Cystic Fibrosis
Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11…
- Trial name
- NCT01897233
- Testing
- Lumacaftor, Ivacaftor
- Where
- 20 sites in United States, Canada
- Volunteers
- 62 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis C, Chronic
Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
The purposes of this Phase 1/2 study are to examine the safety, tolerability, and antiviral activity of ISIS 14803, when given in combination with peginterferon alfa and ribavirin, to patients who either failed to have at least a…
- Trial name
- NCT00062816
- Testing
- ISIS 14803, peginterferon alfa, ribavirin
- Where
- 25 sites in United States
- Volunteers
- 22 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Non Small Cell Lung Cancer, Colorectal Cancer
FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion in participants with advanced solid tumors.
- Conditions
- Non Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- NCT05395052
- Testing
- FT536, Cyclophosphamide, Fludarabine
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Fate Therapeutics
Healthy Adult Women
A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective…
- Trial name
- NCT01398163
- Testing
- 1-Fermented Dairy Product (test), 2-Milk-based non-fermented dairy product(control)
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
Gut Function
Probiotic Intervention for Gut Function
The effect of probiotics on gut function in healthy subjects.
- Trial name
- NCT05155449
- Testing
- Probiotics
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Probi AB
Advanced or Metastatic Biliary Tract Cancer
A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have…
- Trial name
- NCT04838964
- Testing
- MRG003
- Where
- 7 sites in China
- Volunteers
- 15 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Solid Tumors
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in participants with selected tumor indications.
- Trial name
- NCT01772004
- Testing
- Avelumab
- Where
- 74 sites in United States, Belgium and 7 more
- Volunteers
- 1,756 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cholecystitis, Cholelithiasis
Feasibility and Utility of Artificial Intelligence (AI) / Machine Learning (ML) - Driven Advanced Intraoperative Visualization and Identification of Critical Anatomic Structures and Procedural Phases in Laparoscopic Cholecystectomy
The goal of this study is to evaluate the utility and efficacy of an artificial intelligence (AI) model at identifying structures and phases of surgery compared to traditional white light assessment by trained surgeons.
- Conditions
- Cholecystitis, Cholelithiasis, Biliary Dyskinesia
- Trial name
- NCT05775133
- Testing
- ICG
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Activ Surgical
Diphtheria, Tetanus
Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks
A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02257645
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Solid Tumor, Non-small Cell Lung Cancer
A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors
This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors.
- Conditions
- Solid Tumor, Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Colorectal Cancer
- Trial name
- NCT07623369
- Testing
- HH160
- Where
- 3 sites in Australia, China
- Volunteers
- 299 people
- Sponsor
- Huahui Health
Healthy Adult Participants, Gut Microbiomes
DORA - A Study Using Digital Health Tools/Platform to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals
The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital…
- Conditions
- Healthy Adult Participants, Gut Microbiomes, AI
- Trial name
- DORA (NCT07575529)
- Testing
- Synbiotic Nutritional Product
- Where
- Singapore
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with…
- Trial name
- NCT05010577
- Testing
- BX004-A
- Where
- 28 sites in United States, Czechia and 3 more
- Volunteers
- 43 people
- Sponsor
- BiomX, Inc.
Advanced Solid Tumor
A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors
This is a study to evaluate the safety and potential anti-tumor activity of an investigational drug called ARV-6723, in participants with advanced solid tumors.
- Trial name
- NCT07749586
- Testing
- ARV-6723, Pembrolizumab, SOC
- Where
- 4 sites in United States
- Volunteers
- 499 people
- Sponsor
- Arvinas Inc.
Epithelial Tumors, Malignant
Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors
MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.
- Trial name
- MYE Symphony (NCT05969041)
- Testing
- MT-302 (A)
- Where
- 6 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Myeloid Therapeutics
Biliary Tract Cancer
Allogeneic NK Cell ("SMT-NK") in Combination With Pembrolizumab in Advanced Biliary Tract Cancer
The term of biliary tract cancer (BTC) or cholangiocarcinoma refers to all tumors that arise from the biliary tract or the biliary drainage system, including the gallbladder.
- Trial name
- NCT03937895
- Testing
- 'SMT-NK' Inj (allogeneic Natural Killer cell), Pembrolizumab Injection [Keytruda]
- Where
- 2 sites in South Korea
- Volunteers
- 40 people
- Sponsor
- SMT bio Co., Ltd.
Helicobacter Pylori Infection, Gastrointestinal Dysbiosis
Bacillus Probiotics With Bismuth Quadruple Therapy for Helicobacter Pylori Infection
Helicobacter pylori (H. pylori) is a very common gastrointestinal disease that colonises the human gastric mucosa and is a primary risk factor for chronic gastritis, peptic ulcer disease, and gastric cancer.
- Conditions
- Helicobacter Pylori Infection, Gastrointestinal Dysbiosis, Antibiotic-associated Adverse Events
- Trial name
- NCT07827170
- Testing
- RO water, LiveSpo CLAUSY, LiveSpo DIA30
- Where
- Vietnam
- Volunteers
- 336 people
- Sponsor
- Anabio R&D
Cystic Fibrosis
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9)
The present study is designed to assess the safety and tolerability of escalating, multiple ascending doses of Cavosonstat (N91115) in healthy subjects.
- Trial name
- (SNO-9) (NCT02934139)
- Testing
- Cavosonstat
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nivalis Therapeutics, Inc.
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