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229 active trials for Healthy Volunteers

A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants

The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of HYQVIA with ramp-up and no ramp-up dosing in healthy adult participants.

Start: October 2020

Analysis of Crushed and Whole Tablet Genvoya

Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet. The first study sequence will involve a directly observed single dose of the fixed dose formulation of whole Genvoya tablet, with semi-intensive pharmacokinetic serum sampling at time points following the dose. After a washout period of seven days, subjects will then receive a directly observed single dose of a crushed tablet of Genvoya with subsequent semi-intensive pharmacokinetic serum sampling.

Start: April 2019

Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study

The purpose of this study is to define the safety and the biochemical-physiological response of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers.

Start: January 2017

Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children

The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.

Start: September 2016

The Role of Eicosanoids in the Cardiovascular Actions of Inhaled Nanoparticles

Nanoparticles (NPs) are minute pieces of material to which we are exposed every day in the air we breathe. Some are naturally occurring and have no impact on health, whereas others are produced from urban air pollution and can worsen diseases, particularly in the lungs and blood vessels. However, there is great interest in developing new NPs because of their unique properties that are useful for many applications, such as engineering, electronics and for drug delivery. At present it is unclear exactly what effects inhaled NPs have. Our current programme of research is designed to assess whether a specialized group of fats made in the body (called eicosanoids) drive the cardiovascular effects of NPs. The changes in the profiles of these fats will provide unique fingerprints that could be used to predict the actions of new NPs. In the proposed clinical study we shall investigate the effects of both environmental and manufactured carbonaceous NPs on the lungs, blood vessels, blood clotting, and levels of eicosanoids in blood and urine. We have previously investigated the cardiovascular effects of carbon nanoparticles after inhalation in man, and these experiments will investigate how the shape, size and composition of carbon particles influence these responses. These experiments will provide new insight into how NPs affect the body and pave the way for new ways to predict the toxic effects of NPs (reducing the need for animal experiments). The findings will enable the design of novel NP without the harmful characteristics of those found in air pollution.

Start: October 2018

Assessing Deformable Image Registration in the Lung Using Hyperpolarized-gas MRI

Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively measuring physiological lung deformation on a regional basis. This unique imaging technique holds great promise for assessing, validating, and improving the use of Deformable image Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this application is to optimize the hyperpolarized helium tagging MRI technology and establish its usefulness for DIR assessment. Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D) hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung deformation between inhalation and exhalation. Our second objective is to develop physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be used to evaluate a range different DIR algorithms, by comparing the errors between the DIR-derived deformation vector fields and the ground truth represented in the digital phantom. Successful completion of these aims will yield a novel methodology for DIR assessment in the lung for radiotherapy.

Start: July 2016

ANG-3070 in Healthy Adult Participants

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants. This study is comprised of 12 cohorts. 5 single ascending dose (SAD) cohorts 6multiple ascending dose (MAD) cohorts, and 1 single dose food effect (FE) cross-over cohort Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG-3070)

Start: December 2019

A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration

The purpose of this study is to evaluate safety and tolerability after administration of KHK4951 in healthy volunteers and patients with wet age-related macular degeneration.

Start: September 2020

Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects

To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.

Start: September 2019

Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers

This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two active investigational products, in healthy volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.

Start: August 2020

New Technology and Child Health

Background: We are involved in testing new behavioral science methods and measures for future research projects. In the course of these evaluations, we will also test research questions related to parents psychological experiences and how these relate to the responses they have when they encounter different types of communication about child health. We are testing multiple research questions in the course of this research. Objective: - To learn about technologies and approaches to use in future research studies. Eligibility: - Parents (fathers and mothers) of children between the ages of 3-7. Design: As part of the main study, participants will do four tasks: Task 1: Before participants arrive for an in-person visit, they will answer questions online about themselves, their child, and their thoughts and opinions related to health. Task 2: At the in-person visit, participants will watch a short scene from a movie and answer some questions Task 3: At the in-person visit, participants will read information about a child health topic and answer questions Task 4: At the in-person visit, participants will use a virtual reality-based buffet restaurant simulation to make hypothetical food choices for their child...

Start: January 2016

Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.

Start: September 2020

A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers. Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics sub-study.

Start: March 2019

A Study to Evaluate the Metabolism and Excretion of [14C]-CC-92480 in Healthy Male Participants

This is a single-center, open-label study to be conducted in healthy adult male participants. This study is designed to characterize the biotransformation and excretion of [14C]-CC-92480 and to evaluate the safety and tolerability of [14C]-CC-92480 following a single oral dose of [14C]-CC-92480.

Start: October 2020

Healthy Lung Study- Development of 3 Tesla MRI Hardware and Software for Helium-3 Gas Imaging of the Lung: Healthy Volunteer Development Study

Healthy volunteers aged 18-75 will undergo hyperpolarized 3-Helium MRI and pulmonary function testing for the development of tools to assess image signal to noise and reproducibility of spin-density and diffusion-weighted imaging.

Start: September 2007

Whole Blood Specimen Collection From Healthy Subjects

This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.

Start: July 2015

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.

Start: September 2020

Human Oral Detection of Glucose Olygomers

Although salivary contents play a major role in the early stage of food digestion process, their role in taste perception of glucose polymers is essentially unknown. It is hypothesized that the differences in salivary contents, more specifically salivary amylase concentration and activity, influence taste perception of glucose polymers and ultimately eating behavior, which is related to risks in various diseases. The current project is designed to investigate 2 aims. Aim 1 will investigate the variation in salivary contents across individuals and its role in taste perception of glucose polymers. Aim 2 will focus on the role of salivary contents in food liking and disliking.

Start: April 2017

Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation

Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and Individualized programs of rehabilitation

Start: June 2019

GROSS-HIST : Quantification of the Main Circulating Histones During Normal Pregnancy and Pregnancies With Placenta-mediated Complications

Pregnancy generates an increased thrombotic risk, and placental-mediated diseases are a risk factor for cardiovascular diseases, in particular: pre-eclampsia (PE), intrauterine growth retardation (IUGR), retroplacental hematomas (HRP), late intrauterine fetal deaths (LIFD) of placental origin and preterm deliveries of vascular origin. They are responsible for significant maternal-fetal morbidity/mortality. Data published in 2007 by the Haute Autorité de Santé (HAS) show that hypertension and pre-eclampsia are, in France, at the origin of 3 to 8% of the risk of perinatal mortality. During pregnancy, a transitional organ of foetal origin, the placenta, is established, which is essential for the maintenance and harmonious development of the pregnancy. The chorionic villus, in contact with maternal blood in the intervilleous chamber, is the structural and functional unit of the placenta. After the initial implantation phase, the trophoblastic cell constituting the main part of the placental villi differs in two ways: (A) into "citrus cytotrophoblasts" whose cells will fuse to generate the multinucleated outer layer giving the syncytiotrophoblast that ensures fetal-maternal exchanges and endocrine functions of the placenta; (B) into "invasive extra-city cytotrophoblasts" essential for the effective anchoring of the placenta in the decidualized uterine mucosa and for the remodelling of the terminal uterine spiral arteries, whose resistance to blood flow must collapse to allow effective oxygenation of the villi. Extra-city trophoblasts change from an epithelial phenotype to an endothelial phenotype. They may thus be exposed to pro-thrombotic factors such as endothelial cells. A lack of trophoblastic invasion and incomplete remodelling of the spiral uterine arteries are responsible for placental hypo-perfusion, hypoxia and the occurrence of placenta-mediated pathologies (pre-eclampsia, intrauterine growth retardation, retroplacental hematoma, fetal loss and fetal death in utero). The most common placental-mediated disease is pre-eclampsia (5% of births). It corresponds to a complication occurring from the second trimester of pregnancy and which is clinically characterized by high blood pressure, oedema and proteinuria. It is responsible for premature deliveries and is a major cause of intrauterine growth restriction. To date, there is no specific and early biomarker for the occurrence of placental vascular pathologies. Recent developments raise, for example, the question of circulating angiogenesis inhibitory factors (sFlt1, sEng) in pre-eclampsia. With regard to treatment, early administration of low-dose aspirin before 16 weeks of pregnancy seems to reduce the risk of pre-eclampsia, hence the importance of having very early markers of the disease. Discovering such markers is therefore one of the major challenges in strengthening women's follow-up and avoiding subsequent complications. For fetal losses and retroplacental hematoma, the administration of low molecular weight heparin has been shown to be effective. However, these treatments are not specific to placental vascular pathologies. Thus, understanding and exploring the cellular and molecular mechanisms of vascular-placental interface dysfunctions remains necessary to enable targeted management of patients feeding the general principle of precision medicine. Compare the concentrations of (i) circulating histones involved in inflammation, proliferation, migration or cell differentiation (H3-citrullinated histone, acetylated histones (Pan-histones), H1 histone) and (ii) free HMGB1 protein between the three patient groups ("GrossN", "GrossC", "VolS"). The histones H3-citrullinated, acetylated histones (Pan-histones), H1 histone as well as the free HMGB1 protein will be quantified. This choice corresponds to the histones involved in inflammation, proliferation, migration or cell differentiation and can be quantified to date.

Start: March 2019