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229 active trials for Healthy Volunteers

Defining the COVID-19 Immunity Denominator in the Mekong: a Cross-Sectional Seroprevalence Study of SARS-CoV-2 in HealthyVolunteers

Background: In early 2020, many people thought Cambodia would have a serious COVID-19 outbreak due to the high number of Chinese travelers going to Cambodia. But as of June 14, 2020, only 128 cases of COVID-19 have been identified in the country. Many of these cases have been from people who had traveled in Europe. Researchers want to do antibody tests on blood from a sampling of people in Phnom Penh to learn the infection risks for people in the greater Phnom Penh area. Objective: To estimate the level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the blood of people living in Phnom Penh, Cambodia. Eligibility: Healthy males and females age 18-65 living in Phnom Penh since January 2020. Design: A mobile unit will travel to schools, shopping areas, parks, and pagodas around Phnom Penh. Participants will be screened with questions about their age and where they live. They will have blood taken via fingerstick. About 80 uL of blood will be taken. It will be tested for SARS-CoV-2. This visit will take about 30 minutes. If the test result is positive, participants will be contacted by phone. They will be asked to have a second blood draw. This time, 20 mL of blood will be taken. They can have this visit at their home or in a clinic. This visit will take about 30 minutes. If a participant has an adverse event, the mobile units and at-home units will have the tools needed to aid the participant. If needed, the participant will be sent to a nearby clinic. ...

Start: June 2021

Phase 1 Study of Epetraborole Tablets

This is a Phase 1b double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy adult subjects for up to 28 days.

Start: June 2021

A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults

This is a first-in-human study in adult healthy participants consisting of two parts. In Part 1, participants will receive one dose of study drug (LEO 153339) or placebo; in Part 2, participants will receive multiple doses of study drug or placebo. The participants will stay in the clinic for 6 days (Part 1) or for 12 days (Part 2) to have the study doctor assess their safety and to investigate how quickly and to what extent LEO 153339 (and the breakdown product) is absorbed, transported, and eliminated from the body. The purpose is to assess the safety and tolerability of LEO 153339 when compared to a placebo with no active ingredient.

Start: May 2021

A Study to Assess the Safety and Tolerability of E6742 in Japanese Healthy Adult Participants

The primary purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending oral doses of E6742 in Japanese healthy adult participants.

Start: December 2020

A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women

The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the relative infant dose (RID) expressed as a percent of the daily maternal dose.

Start: May 2021

Study to Investigate Safety, Tolerability, Pharmacokinetics, and Drug-drug Interaction of Multiple Oral Doses of BAY1830839 in Healthy Male Participants

The aim of this study is to investigate safety, tolerability and pharmacokinetics of increasing repeated oral doses of BAY1830839 in healthy male participants including the investigation of any potential drug-drug interactions of BAY1830839 with midazolam and methotrexate. In addition, the effects of BAY180839 on exploratory pharmacodynamics biomarkers in healthy participants will be investigated.

Start: June 2019

The MURDOCK Study Registry and Biorepository Horizon 1.5

The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a large-scale community registry and biorepository that can be used as a vehicle for future health services, epidemiologic, clinical trials and other omics-related research.

Start: February 2009

Development of Hardware and Software for Pulmonary Magnetic Resonance Imaging Using Inhaled Tracer Gases

This is a single centre study. The overarching hypothesis of this study is that MRI with inhaled tracer gases can provide high quality images of lung function to complement conventional 1H MRI. The study interventions do not affect the standard of care.

Start: June 2021

A Study to Assess the Safety and Tolerability of E8001 in Healthy Male Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E8001 of single ascending dose intravenous infusions in healthy male participants.

Start: October 2020

Study to Evaluate Absorption, Metabolism, and Excretion, of TAK-994 in 6 Healthy Male Adults

The aim of this study is to understand how TAK-994 is processed by the body. This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994.

Start: April 2021

Bioavailability and Food Effect Study of Two Formulations of TAK-906

The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting. This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906.

Start: April 2021

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect

The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants. This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617.

Start: September 2019

Energy Expenditure Responses to Different Temperatures

Background: - The way that the body burns calories is known as energy expenditure. Some studies show that when we are cold, we burn more calories to keep our bodies warm. Brown fat is a special kind of fat that can use energy to keep the body warm. Small animals and infants have been known to have brown fat for many years. Recently, it has been suggested that adult humans also have brown fat. If brown fat becomes active (burns calories) in adult humans when exposed to cold, then these people would tend to burn off more calories and might not gain weight easily. Learning more about the relationship between energy expenditure, brown fat, environmental temperature, and body temperature may help explain why some people become obese and other people do not. Objectives: To better understand how the body burns calories when exposed to different temperatures. To study brown fat and how it burns calories in cold temperatures. Eligibility: Healthy men between 18 and 35 or 55 and 75 years of age. Healthy women between 18 and 35 years of age. To control for ethnicity, participants must be non-Hispanic whites or African Americans. Design: Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Participants will stay in the Metabolic Unit of the National Institutes of Health Clinical Center as inpatients for no more than 14 days. The length of the hospital stay will depend on how participants respond to the different study temperatures. Every afternoon, participants will walk for 30 minutes on a treadmill. All meals will be provided. Participants will stay up to 5 hours per day in a specialized room with different temperature settings. Temperatures will range from about 61 degrees to 88 degrees Fahrenheit. Body temperature, activity, calorie burning, and cold/hot sensations will be monitored. On the study day of the coldest temperature, participants will have an imaging study to look for brown fat activity. Participants will be compensated for their time and participation at the end of the study.

Start: April 2012

Drug-drug Interaction Study of CTP-543 and Rifampin in Healthy Adult Subjects

This is a Phase 1 open-label study of the effect of rifampin on the pharmacokinetics of CTP-543 in healthy subjects.

Start: May 2021

Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants

This is a randomized, participant- and investigator-blinded, placebo-controlled, single ascending and multiple oral dose study in healthy participants. The study consists of two parts: Part A is a single ascending dose (SAD) study with 4 planned cohorts of 8 participants each including a food effect cohort with 10 participants Part B is a multiple dose (MD) study with 1 planned cohort of 9 participantsEligible participants will be randomized to receive either a single dose or a dose q24h x 3 day of either INE963 or placebo depending on which part of the study the participant will be randomized to. Safety, tolerability, and pharmacokinetics will be assessed over a period of 16 days for single dose and 18 days for multiple dose for each participant.

Start: May 2021

A Trial to Learn How BAY1817080 Moves Into, Through and Out of the Body and How Safe it is in Healthy Chinese Men

Researchers are looking for a better way to treat chronic cough. Before patients with medical conditions can join clinical trials, researchers do trials in healthy participants first to understand how the body acts on the new treatment and learn how safe it is. In this trial, the researchers will study how much of the trial drug, BAY1817080, gets into the blood in a small number of participants. The trial will include about 39 healthy Chinese male who are aged 18 to 45. For this trial participants will be divided in 3 groups. Groups 1 and 2 will take either dose 1 or dose 2 of BAY1817080 or placebo 1 time. Participants of groups 3 will take dose 3 of BAY1817080 or placebo one time at the first day and continue to take dose 3 of BAY1817080 twice a day from day 7 to day 16 of the trial. On day 17 they will take only one dose 3 of BAY1817080. All participants will take BAY1817080 or a placebo as a tablet by mouth. For this trial, the participants in Groups 1 and 2 will stay at the trial site for up to 10 days. The participants in Group 3 will stay at the trial site for up to 26 days. The trial will last up to 4 weeks for the participants in Groups 1 and 2, and 6 weeks for the participants in Group 3. During the trial, the doctors will take blood and urine samples and check the participants blood pressure, pulse rate and electrocardiogram (ECG). The participants will answer questions about how they are feeling to check their general wellbeing.

Start: April 2021

Study of BIIB091 Modified Release Formulations in Healthy Participants

The primary objectives of this study are: to evaluate the pharmacokinetic (PK) profiles of BIIB091 modified release (MR) formulations in healthy participants after single dose administration in the fasted state (Part 1); to determine the PK of a single dose of the selected BIIB091 MR formulation in the fed and fasted state in healthy participants (Part 2); to evaluate the PK of the selected BIIB091 MR formulation in healthy participants after multiple dose administration (Part 3). The secondary objectives of this study are: to determine the relative bioavailability of a single dose of the BIIB091 MR formulations compared to that of the immediate release (IR) drug in capsule (DiC) reference formulation in healthy participants in the fasted state, to assess the safety and tolerability of single doses of BIIB091 when administered as MR formulations in healthy participants in the fasted state (Part 1); to assess the safety and tolerability of single dose of BIIB091 when administered as the selected MR formulation in healthy participants in the fed and fasted states, to determine the relative bioavailability of single dose of the selected BIIB091 MR formulation in healthy participants taking a proton pump inhibitor (PPI) compared to healthy participants not taking a PPI, in the fasted state, to determine the relative bioavailability of single dose of the selected BIIB091 MR formulation in healthy participants taking a cytochrome P450 (CYP) 3A4 inhibitor compared to healthy participants not taking a CYP3A4 inhibitor, in the fasted state, to assess the safety and tolerability of single dose of BIIB091 when administered as the selected MR formulation in healthy participants taking a PPI in the fasted state, to assess the safety and tolerability of single dose of BIIB091 when administered as the selected MR formulation in healthy participants taking a CYP3A4 inhibitor in the fasted state (Part 2); to assess the safety and tolerability of multiple doses of BIIB091 when administered as the selected MR formulation in healthy participants (Part 3).

Start: September 2020

New Heart Imaging Techniques to Evaluate Possible Heart Disease

Background: - Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography. Objectives: - To compare heart MRI techniques with other tests used to diagnose heart disease. Eligibility: - People at least 18 years of age who either have or may have heart disease, or are healthy volunteers. Design: Participants will be screened with a physical exam, medical history, and blood tests. They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease. Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan. No treatment will be provided as part of this protocol.

Start: July 2011

Normal Values of Parameters of Thrombin Generation in Function of Different Tissue Factor Concentrations

The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP).According to the clinical context, different TF(Tissue Factor) concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.The aim of the study is to determine the normal values of TG (Thrombin Generation) in fresh PRP and in PPP with different TF concentrations.

Start: April 2021

A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants

This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only. Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in healthy adult participants. Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4) to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B under fasted conditions and explore safety, tolerability, and PK effects of food on Formulation A and Formulation B in healthy adult participants.

Start: January 2021