Clinical trials: Phase I
Bioavailability, Healthy Subjects
A Bioavailability Study With Alternate Methods of Administration of Naloxegol Tablets, and Solution
This clinical study is an open-label, randomized, 4-period, 4-treatment, crossover, single-center, single-dose bioavailability study with alternate methods of administration of crushed naloxegol tablets, 25 mg and of a naloxegol…
- Trial name
- NCT02446171
- Testing
- Naloxegol 25 mg tablet, crushed, suspended in water, given orally, Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube, Naloxegol 25 mg (10 mL oral solution)
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Prostate Cancer, Non-small Cell Lung Cancer
Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies
Primary Objectives: To characterize the safety and tolerability of isatuximab in combination with REGN2810 in participants with metastatic, castration-resistant prostate cancer (mCRPC) who were naïve to anti-programmed cell…
- Trial name
- NCT03367819
- Testing
- Isatuximab SAR650984, Cemiplimab REGN2810
- Where
- 16 sites in United States, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Sanofi
Prostate Cancer, Prostatic Neoplasms
Docetaxel (Taxotere) and Imatinib Mesylate (Gleevec) in Hormone Refractory Prostate Cancer
This trial is designed to determine the proper doses of Docetaxel and Imatinib mesylate to be used to treat hormone refractory prostate cancer and to evaluate the safety and efficacy of the treatment.
- Trial name
- NCT00861471
- Testing
- Docetaxel, Imatinib Mesylate
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- NYU Langone Health
Severe Hemophilia A
Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A
This Phase 1/2 study will be a dose escalation study in adults in 5 cohorts (named cohorts 1, 2, 3, 5 and 6), with the main purpose to assess the safety of subcutaneous injection of OCTA101 (a human-cl rhFVIII and recombinant…
- Trial name
- NCT04046848
- Testing
- OCTA101
- Where
- Bulgaria
- Volunteers
- 36 people
- Sponsor
- Octapharma
SARS-CoV-2 Infection, COVID-19
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
- Trial name
- NCT04368728
- Testing
- BNT162b1, BNT162b2, BNT162b2SA
- Where
- 175 sites in United States, Argentina and 4 more
- Volunteers
- 46,969 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Multiple Myeloma
A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM).
- Trial name
- NCT01063907
- Testing
- KW-2478, Bortezomib
- Where
- 26 sites in United States, Philippines and 1 more
- Volunteers
- 95 people
- Sponsor
- Kyowa Kirin Co., Ltd.
DS Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma
Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma
This phase II trial studies lenalidomide, dexamethasone, and clarithromycin in treating patients who have undergone stem cell transplant for multiple myeloma.
- Conditions
- DS Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Trial name
- NCT00445692
- Testing
- Clarithromycin, Dexamethasone, Lenalidomide
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fred Hutchinson Cancer Center
ATP-Binding Cassette Subfamily C Member 6 Deficiency, Pseudoxanthoma Elasticum
Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ABCC6 Deficiency Causing PXE
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics PD) of multiple ascending doses of INZ-701, an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) recombinant…
- Conditions
- ATP-Binding Cassette Subfamily C Member 6 Deficiency, Pseudoxanthoma Elasticum, Generalized Arterial Calcification of Infancy
- Trial name
- NCT05030831
- Testing
- INZ-701
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 10 people
- Sponsor
- Inozyme Pharma
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.
- Trial name
- NCT01505894
- Testing
- BI 409306
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma
PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer
This phase I trial studies side effects and best dose of PSCA-chimeric antigen receptor (CAR) T cells in treating patients with prostate stem cell antigen positive (PSCA+) castration resistant prostate cancer that has spread to…
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- Trial name
- NCT03873805
- Testing
- Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- City of Hope Medical Center
Cardiovascular Diseases, Kidney Failure, Chronic
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
- Trial name
- NCT01241539
- Testing
- Dabigatran etexilate
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
Squamous Cell Carcinoma of the Head and Neck
Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History
This is a research study that plans to learn more about the safety and tolerability of an investigational drug called Olaparib, in combination with radiation therapy and cetuximab.
- Trial name
- NCT01758731
- Testing
- Olaparib, Cetuximab, Radiation Therapy
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Colorado, Denver
Healthy
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.
- Trial name
- NCT01999231
- Testing
- ESAT6-CFP10
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Leukemia, Lymphoma
Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers
Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells.
- Conditions
- Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- Trial name
- NCT00619645
- Testing
- busulfan, cyclosporine, fludarabine phosphate
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, Davis
Brain Injury Traumatic Severe (Diagnosis), Coma
Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness
Phase 1 of the STIMPACT trial is an open label,dose-escalation,safety study of intravenous (IV) methylphenidate (MPH) therapy in patients with disorders of consciousness (DoC) caused by severe brain injuries.
- Conditions
- Brain Injury Traumatic Severe (Diagnosis), Coma, Consciousness, Level Altered, Anoxic Brain Injury
- Trial name
- STIMPACT (NCT03814356)
- Testing
- Methylphenidate
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital
Colorectal Cancer
A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery
This study is open to people with newly diagnosed colorectal cancer. People who are scheduled for surgery can participate. People either get a medicine called BI 765063 combined with ezabenlimab or combined with pembrolizumab in…
- Trial name
- NCT05446129
- Testing
- Ezabenlimab, BI 765063, Pembrolizumab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Lymphoma
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver…
- Trial name
- NCT00039195
- Testing
- filgrastim, rituximab, carboplatin
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Corneal Edema, Corneal Endothelial Dysfunction
A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction.
- Trial name
- CLARA (NCT06041256)
- Testing
- AURN001, Corneal Endothelial Cells, Y27632
- Where
- 20 sites in United States, Canada
- Volunteers
- 97 people
- Sponsor
- Aurion Biotech
Phase I: Relapsed or Refractory B-cell Malignancies, Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma
Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
This is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in Chinese adult subjects with R/R MCL, CLL and other B-cell malignancies.
- Conditions
- Phase I: Relapsed or Refractory B-cell Malignancies, Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma, Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia
- Trial name
- NCT03932331
- Testing
- Acalabrutinib
- Where
- 23 sites in China
- Volunteers
- 105 people
- Sponsor
- AstraZeneca
Postsurgical Pain
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to…
- Trial name
- NCT04203537
- Testing
- CA-008
- Where
- 4 sites in United States
- Volunteers
- 193 people
- Sponsor
- Concentric Analgesics
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