Clinical trials: Phase I
Hantavirus Pulmonary Infection, Immunisation
Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device
This is a Phase 1, randomized, placebo controlled, double-blind, dose escalation trial of 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03682107
- Testing
- Andes virus DNA vaccine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Ophthalmological Agent Toxicity, Bacterial Conjunctivitis
Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best…
- Trial name
- NCT06363292
- Testing
- PRO-231, VIGAMOXI®
- Where
- Mexico
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Lung Cancer
Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating…
- Trial name
- NCT00852644
- Testing
- computed tomography, fludeoxyglucose F 18, hypofractionated radiation therapy
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Boston Medical Center
Bacterial Infection
Safety of Intravenous Apramycin in Adults
A Phase I, open label study of a single dose of 30 mg/kg of apramycin administered intravenously (IV) over 30 (+/- 5) minutes. Twenty subjects will be enrolled in the study to one of 5 cohorts, T1-T5, each corresponding to a…
- Trial name
- NCT05590728
- Testing
- Apramycin (EBL-1003)
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Colorectal Neoplasms, Colorectal Carcinoma
ISIS 183750 With Irinotecan for Advanced Solid Tumors or Colorectal Cancer
Background: Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other chemotherapy drugs.
- Conditions
- Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumors
- Trial name
- NCT01675128
- Testing
- ISIS 183750, Irinotecan
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Type2 Diabetes Mellitus
Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin
The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin, glimepiride or sitagliptin.
- Trial name
- NCT02956044
- Testing
- Bexagliflozin, Metformin, Glimepiride
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Theracos
Diamond Blackfan Anemia
Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia
The purpose of this study is to determine the safety and dosing of drug Sotatercept, as a subcutaneous injection, to stimulate production of red blood cell production. To be given every 28 days for up to four doses.
- Trial name
- ACE-011-DBA (NCT01464164)
- Testing
- Sotatercept, Sotatercept with prednisone boost
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Northwell Health
Tuberculosis, HIV
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed…
- Trial name
- NCT02906007
- Testing
- Bedaquiline
- Where
- 4 sites in Haiti, South Africa
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pneumonia
A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya
This study aimed to determine whether PATH-wSP, a vaccine against a germ that causes pneumonia, is safe and induces immune responses in adults and toddlers. The study vaccine was compared to placebo.
- Trial name
- NCT02543892
- Testing
- PATH-wSP
- Where
- Kenya
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- PATH
Alternating Hemiplegia of Childhood
Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)
WHO: The investigators are recruiting children and young adults to participate in a research study who: 1. Have been diagnosed with Alternating Hemiplegia of Childhood (AHC) 2. Are between the ages of 6 months - 25 years old 3.
- Trial name
- AHC-SO (NCT00931164)
- Testing
- Sodium Oxybate
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Utah
Solid Tumors
Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors
The purpose of this study was to assess the safety of the combination of relacorilant (CORT125134), a novel glucocorticoid receptor (GR) antagonist, and nab- paclitaxel in participants with solid tumors and to determine the…
- Trial name
- NCT02762981
- Testing
- Relacorilant with nab-paclitaxel
- Where
- 4 sites in United States
- Volunteers
- 85 people
- Sponsor
- Corcept Therapeutics
Prostate Cancer
Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC
The purpose of the initial (phase I) portion of this study is to find a dose level and administration schedule of the study drug, 225Ac-J591, that can be given without severe side effects.
- Trial name
- NCT04506567
- Testing
- Multiple Dose of 225Ac-J591 at 45 KBq/kg, Multiple Dose of 225Ac-J591 at 55 KBq/kg, Multiple Dose of 225Ac-J591 at 65 KBq/kg
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Weill Medical College of Cornell University
Lung Cancer
Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy
The goal of this clinical research study is to evaluate the outcome of a standard radiation treatment called stereotactic radiotherapy (SRT) for NSCLC.
- Trial name
- NCT02357992
- Testing
- Stereotactic Body Radiotherapy (SABR)
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- M.D. Anderson Cancer Center
AMN, AMN Gene Mutation
A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN)
This is a Phase 1/2 randomized, blinded, dose-escalation study to evaluate the safety and efficacy of intrathecal (IT) administration of SBT101, a recombinant adeno-associated virus serotype 9 (AAV9) containing a functional copy…
- Conditions
- AMN, AMN Gene Mutation, X-ALD
- Trial name
- PROPEL (NCT05394064)
- Testing
- SBT101 Treatment
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 9 people
- Sponsor
- SwanBio Therapeutics, Inc.
Head and Neck Squamous Cell Carcinoma
Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma
The purpose of this research is to see whether metformin can improve the response rate in patients undergoing chemotherapy and radiation for squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx.
- Trial name
- NCT02949700
- Testing
- Metformin
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- Baylor College of Medicine
Colorectal Neoplasm, Colorectal Cancer
New Individualized Therapy Trial for Metastatic Colorectal Cancer
The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in combination with panitumumab for the treatment of stage IV colorectal cancer that has spread to the liver.
- Trial name
- NITMEC (NCT00867334)
- Testing
- Imatinib mesylate and panitumumab, Standard-of-care treatment with panitumumab
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Inova Health Care Services
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer
This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or without fludarabine phosphate followed by…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT00089011
- Testing
- fludarabine phosphate, total-body irradiation, mycophenolate mofetil
- Where
- 5 sites in United States, Italy
- Volunteers
- 150 people
- Sponsor
- Fred Hutchinson Cancer Center
Malaria
Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of Ruxolitinib With Artemether-lumefantrine
Phase 1, single -center study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics\& pharmacodynamics.
- Trial name
- NCT04456634
- Testing
- 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)
- Where
- Australia
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Glioblastoma Multiforme, Glioma of Brain
A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection
In the proposed trial, patients will be administered ribociclib+everolimus prior to surgical resection of their tumor. Recurrent GBM patients will be randomized into one of the three time-interval cohorts for the first two dose…
- Trial name
- NCT03834740
- Testing
- Ribociclib, Everolimus
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants
The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
- Trial name
- NCT03316976
- Testing
- Dexlansoprazole
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
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