Clinical trials: Safety Study
Healthy, HIV
A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074
This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in HIV-infected and HIV-uninfected individuals.
- Trial name
- NCT02511990
- Testing
- 3 mg/kg, single dose IV administration of 10-1074, 10 mg/kg, single dose IV administration of 10-1074, 30 mg/kg, single dose IV administration of 10-1074
- Where
- 2 sites in United States, Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Thrombocytopenia, Neutropenia
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin…
- Conditions
- Thrombocytopenia, Neutropenia, Lymphopenia, Anemia
- Trial name
- NCT00771810
- Testing
- TXA127
- Where
- 6 sites in United States
- Volunteers
- 34 people
- Sponsor
- Tarix Pharmaceuticals
Advanced Solid Tumors
Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
This is a first-in-human, Phase I, multicenter, open label, dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically…
- Trial name
- NCT03348514
- Testing
- CPX-POM - 30 mg/m^2, CPX-POM - 60 mg/m^2, CPX-POM - 120 mg/m^2
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- CicloMed LLC
Magnetic Resonance Imaging
Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects
The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.
- Trial name
- NCT03399214
- Testing
- IOP Injection
- Where
- Taiwan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- MegaPro Biomedical Co. Ltd.
Kidney Transplantation, SARS-CoV-2 Acute Respiratory Disease
Safety and Immunogenicity of 2-dose Inactivated COVID-19 Vaccine in Kidney Transplant Recipients
The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has a major impact on transplant recipients, with mortality rates up to 20%.
- Conditions
- Kidney Transplantation, SARS-CoV-2 Acute Respiratory Disease, Vaccine
- Trial name
- NCT04969614
- Volunteers
- 300 people
- Sponsor
- West China Hospital
Male Hypogonadism
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
- Trial name
- NCT01403116
- Testing
- Oral testosterone undecanoate, topical testosterone gel
- Where
- 30 sites in United States, Germany
- Volunteers
- 325 people
- Sponsor
- Clarus Therapeutics, Inc.
Infection, Bacterial
A First-in-Human Study With XAB05 in Healthy Subjects
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
- Trial name
- NCT05307406
- Testing
- Experimental
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Xenothera SAS
Pulmonary Disease, Chronic Obstructive, COPD
Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive
- Trial name
- NCT00396604
- Testing
- indacaterol maleate
- Where
- Belgium
- Volunteers
- 51 people
- Sponsor
- Novartis
Neurogenic Lower Urinary Tract Dysfunction
Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia
This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.
- Trial name
- NCT02034604
- Testing
- Naftofidil, Tamsulosin
- Where
- South Korea
- Volunteers
- 194 people
- Sponsor
- Samsung Medical Center
Frail Elderly
Resistance Training to Optimize Health in Pre-frail Older Adults
Exercise programs, particularly resistance training programs using weights or resistance bands, can help improve or maintain mobility and function in older adults, preserve independent living, and improve quality of life.
- Trial name
- NCT02593084
- Testing
- Higher Intensity Resistance Training, Lower Intensity Resistance Training
- Where
- Canada
- Volunteers
- 36 people
- Sponsor
- McMaster University
Hodgkin Lymphoma, Lymphocytic Leukemia
Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies
Background: Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in the curative treatment of a number of pediatric malignancies.
- Conditions
- Hodgkin Lymphoma, Lymphocytic Leukemia, Mixed Cell Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT00013533
- Testing
- Stem cell transplantation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
Respiratory Syncytial Virus (RSV)
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir…
- Trial name
- THAI-CARES RSV (NCT06873633)
- Testing
- Remdesivir
- Where
- 8 sites in Thailand
- Volunteers
- 120 people
- Sponsor
- PENTA Foundation
Head and Neck Cancer
Interleukin-2 Gene or Methotrexate in Treating Patients With Recurrent or Refractory Stage III or Stage IV Head and Neck Cancer
RATIONALE: Inserting the gene for interleukin-2 into head and neck cancer cells may make the body build an immune response to kill the tumor cells.
- Trial name
- NCT00006033
- Testing
- gene therapy, interleukin-2 gene, methotrexate
- Where
- United States
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Type 2 Diabetes Mellitus
Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients
The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessment of AUC and Cmax of dapagliflozin
- Trial name
- NCT01055652
- Testing
- Dapagliflozin
- Where
- 2 sites in Japan
- Volunteers
- 28 people
- Sponsor
- AstraZeneca
Kidney Transplant Patients
Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients
This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.
- Trial name
- NCT01680952
- Testing
- A) TEST, B) CONTROL
- Where
- 7 sites in South Korea
- Volunteers
- 158 people
- Sponsor
- Yonsei University
Asthma
Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation solution will be investigated in subjects with mild bronchial asthma.
- Trial name
- NCT01478152
- Testing
- Drug-like Medical Device: Ectoin Inhalation Solution
- Where
- Germany
- Volunteers
- 18 people
- Sponsor
- Bitop AG
Covid19 Vaccine
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study
The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine who are generally healthy or with stable pre-existing health conditions and have received 2 doses of Placebo in the main study CT-COV-21
- Trial name
- NCT05048849
- Testing
- MVC-COV1901(S protein with adjuvant)
- Where
- 11 sites in Taiwan
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Medigen Vaccine Biologics Corp.
Acute Pain
Pharmacokinetics and Safety of MNK-155 in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain
An open-label study of the pharmacokinetics (PK) and safety of MNK-155 in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain.
- Trial name
- NCT02767349
- Testing
- MNK-155
- Where
- United States
- Sponsor
- Mallinckrodt
Psoriasis
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV.
- Trial name
- NCT02195349
- Testing
- GSK2831781
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malignant Neoplasms, Cancer
Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures
CONSTELAR is a prospective, single-arm, multi-specialty registry designed to evaluate the safety and intraoperative performance of the RonovoTM robotic surgical platform in adult patients undergoing elective oncological surgery.
- Trial name
- CONSTELAR (NCT07632638)
- Testing
- RonovoTM Robotic Surgical Platform
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- Instituto do Cancer do Estado de São Paulo