Clinical trials: Phase 1
Gastroenteritis Norovirus
Phase I Norovirus Challenge Model
This is a safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to 48 healthy non-pregnant adults, 18-49 years of age, negative for COVID-19 by antigen testing at the time of norovirus…
- Trial name
- NCT04174560
- Testing
- Norovirus GII.4 Challenge Pool
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diabetic Foot Ulcer
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers
- Trial name
- NCT03624023
- Testing
- TWB-103
- Where
- 2 sites in Taiwan
- Volunteers
- 10 people
- Sponsor
- Transwell Biotech Co., Ltd.
Advanced Breast Cancer
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
As part of the global clinical development program for Palbociclib, studies are planned in cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients, as required by the Chinese Health…
- Trial name
- NCT02499146
- Testing
- Palbociclib, Letrozole
- Where
- 7 sites in China
- Volunteers
- 26 people
- Sponsor
- Pfizer
Respiratory Syncytial Virus
Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults
Background: Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two.
- Trial name
- NCT03049488
- Testing
- VRC-RSVRGP084-00-VP, Aluminum Hydroxide Suspension
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Non-Hodgkin's Lymphoma, Hodgkin Lymphoma
An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma
The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.
- Conditions
- Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma
- Trial name
- NCT01592370
- Testing
- Nivolumab, Ipilimumab, Lirilumab
- Where
- 43 sites in United States, Belgium and 4 more
- Volunteers
- 320 people
- Sponsor
- Bristol-Myers Squibb
Metastatic Cancer, Solid Tumor
Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
This is the first study to test Sym022 in humans. The primary purpose of this study is to see if Sym022 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas…
- Conditions
- Metastatic Cancer, Solid Tumor, Lymphoma
- Trial name
- NCT03489369
- Testing
- Sym022
- Where
- 3 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- Symphogen A/S
Hodgkin's Disease, Non-Hodgkin's Lymphoma
Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies
The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide.
- Trial name
- SAHA (NCT00691210)
- Testing
- Vorinostat, Niacinamide, Etoposide
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Columbia University
Healthy
Absorption, Metabolism and Excretion of [14C]-Lasmiditan - Single Oral Dose Administration
This study will be an open-label, nonrandomized, absorption, metabolism, and excretion study of [14C]-lasmiditan administered as a 200-milligrams (mg) (approximately 100 microcuries[µCi]) oral solution to 8 healthy males and…
- Trial name
- NCT03040362
- Testing
- [14C]-lasmiditan
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Adenocarcinoma, Pancreatic Neoplasms
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors
This study is to evaluate the combination of an investigational drug X-82 with everolimus in the treatment of pancreatic neuroendocrine tumors.
- Trial name
- NCT01784861
- Testing
- X-82, Everolimus
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Washington University School of Medicine
Type 1 Diabetes Mellitus
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past…
- Trial name
- NCT00385697
- Testing
- Teplizumab
- Where
- 115 sites in United States, Canada and 14 more
- Volunteers
- 554 people
- Sponsor
- MacroGenics
Gastroesophageal Reflux
Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease
The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.
- Trial name
- NCT00847210
- Testing
- Dexlansoprazole MR
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Takeda
Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This trial studies the side effects and best dose of AVB-S6-500 when given together with durvalumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum therapy or has come…
- Conditions
- Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma
- Trial name
- NCT04019288
- Testing
- Batiraxcept, Durvalumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- M.D. Anderson Cancer Center
Healthy Volunteer, Female, Breast
Effect of Denosumab on Cellular Biomarkers in the Human Breast
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
- Trial name
- NCT02099461
- Testing
- Denosumab, Percutaneous core needle breast biopsy
- Where
- 3 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Amgen
Bladder Cancer
Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer
The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer.
- Trial name
- NCT00318643
- Testing
- Mitomycin C, Chemophase
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halozyme Therapeutics
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy Volunteers
A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
The purpose of this study is to evaluate the effect of single dose intravenous rifampin on the single-dose PK of orally administered TAK-906.
- Trial name
- NCT04121078
- Testing
- TAK-906, Rifampin
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy Volunteers
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
The purpose of this study is to compare the PK of single dose of Vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03961308
- Testing
- Vedolizumab SC
- Where
- 2 sites in United States
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Takeda
HIV Infections
Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult.
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult…
- Trial name
- HVTN139 (NCT05182125)
- Testing
- AdC6-HIVgp140, AdC7-HIVgp140, CH505TF gp120
- Where
- 6 sites in South Africa
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
Diffuse Large B Cell Lymphoma
Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma
This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL.
- Trial name
- NCT01004991
- Testing
- rituximab, cyclophosphamide, vincristine
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Weill Medical College of Cornell University
Non-small Cell Lung Carcinoma
A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)
The purpose of this study is to determine the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung…
- Trial name
- NCT02039674
- Testing
- Pembrolizumab, Paclitaxel, Carboplatin
- Volunteers
- 267 people
- Sponsor
- Merck Sharp & Dohme LLC