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229 active trials for Healthy Volunteers

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants

The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and single ascending intravenous (IV) doses of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants.

Start: October 2020

Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers

The goal of the present study is to confirm in humans the in-vivo bioconversion of a Prodrug (PRX-P4-003) to (-)-fencamfamine (FCF) the active moiety when orally administered as a single microdose. A second component of the study will evaluate effect of food on pharmacokinetics of PRX-P4-003.

Start: February 2021

Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.

The planned study is to determine the safety and pharmacokinetic properties of CPL207280 compound after single and multiple (two weeks) administration in healthy volunteers.

Start: May 2020

Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR). V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus suicide recombination are mutational/recombinational processes targeting Ig loci influencing BCR expression. Study of these events is essential for B cell function analysis. Our project will provide the normal reference values using high throughput sequencing-based protocols.

Start: June 2021

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease

The purpose of the study is to assess the safety and tolerability of AG-946 in healthy volunteers after oral administration of single ascending doses (SAD) and multiple ascending doses (MAD) of AG-946 over 14 days of dosing, and to identify a range of doses that are safe and pharmacologically active in participants with sickle cell disease. The SAD and MAD parts of the study will be randomized and double-blinded, and will assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of AG-946 as well as the effect of food (SAD only) on the pharmacokinetics (PK) of AG-946. The sickle cell disease (SCD) part of the study will be non-randomized and open-label, and is designed to identify 1 or more safe and tolerable dose(s) of AG-946 with potential activity in the treatment of participants with sickle cell disease (SCD).

Start: July 2020

Platform for Clinical Trials in Nutrition and Health

Despite the known link between dietary patterns and disease, it has been observed that the specific response of each individual to dietary components highly varied, and this may limit the impact of the nutritional interventions to improve public health. These observations provided the basis to the development of the Nutritional Genomics at the beginning of the 90s, which main goal was to study the interaction between dietary factors and the genome that modulate phenotypic expression. From this idea, in the recent years, Precision Nutrition has been emerged as a therapeutic approach that takes into account all individual's characteristics to develop targeted nutritional advices. The main goal of Precision Nutrition is to maintain or improve health by using genetics, phenotypic, clinical, dietary and other information to provide more precise and more efficacious personalized healthy eating advice and to motivate appropriate dietary changes. However, all the genotype-dependent advice must be based on scientific evidence. Most of the available evidence in support of personalized nutrition has come from observational studies with risk factors as outcomes, and it was needed randomized controlled trials using clinical endpoints to ratify these results. The main objective of the Platform for Clinical Trials in Nutrition and Health (GENYAL) is to contribute to Precision Nutrition Research by the construction, for the first time, of a human gene and phenotype database to be used in: 1) The evaluation of the efficacy of different foods, functional foods and bioactive compounds capsules on general population and by genotypes and 2) The performance of nutritional genetics and nutrigenomics studies. For that purposes, GENYAL has a permanent recruitment of volunteers, which are phenotypically and genotypically characterized, and give consent to be contacted to perform clinical trials and nutritional intervention studies. Therefore, GENYAL may help to increase the existing knowledge for moving along to Nutritional Genomics research to its practical application in Precision Nutrition; contributing in the improvement in health and disease prevention through dietary recommendations based on the genome.

Start: November 2011

A PET Study of Nicotine From myBlu E-cigarette Use

This is a single-center, exploratory PET-study of deposition, disposition and brain uptake [11C]nicotine when given to smokers as two different formulations via mybluTM e-cigarette system.

Start: March 2020

A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants

This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.

Start: April 2021

Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Primary Objective: To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects. To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects Secondary Objective: - To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions

Start: April 2021

Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.

Start: May 2021

Chronic Effects of Wide-pulse Neuromuscular Electrostimulation on Neuromuscular and Functional Properties in Healthy Subjects

Neuromuscular electrostimulation (NMES) is a technique used in the clinical and training fields to increase the strength of a muscle group.The recent use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. This more global solicitation of the neuromuscular system (i.e. information going back to the spinal cord and even to the brain) prejudges more nervous adaptations and therefore a greater functional benefit. The first aim of this study is to evaluate and compare the force gains induced by 2 NMES training programs (CONV, WP) applied on knee extensors in healthy subjects for 6 weeks.The second aim is to understand the neuromuscular adaptations involved in these gains, as well as the functional benefit resulting from these improvements.

Start: May 2021

Mobile Attention Retraining in Overweight Female Adolescents

Background: People are constantly exposed to unhealthy foods. Some studies of adults show that training attention away from unhealthy foods might reduce overeating. Researchers want to see what happens in the brain when teens train their attention away from food through a program on a smartphone. Objective: To study the relationship between eating patterns, body weight, and how the brain reacts to different images. Eligibility: Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th percentile for age). Design: Participants will have 6 visits over about 8 months. Visit 1: participants will be screened with: Height, weight, blood pressure, and waist size measurements Medical history Physical exam Urine sample DXA scan. Participants will lie on a table while a very small dose of x-rays passes through the body. Questions about their general health, social and psychological functioning, and eating habits Parents or guardians of minor participants will answer questions about their child s functioning and demographic data. Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will include some or all of these procedures: Blood drawn MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in a strong magnetic field. A device will be placed over the head. Meals provided. Participants will fill out rating forms. Simple thinking tasks A cone containing magnetic field detectors placed onto the head Medical history Physical exam Urine sample Participants will be assigned to a 2-week smartphone program that involves looking at pictures. Participants will complete short tasks and answer some questions about their eating habits and mood on the smartphone.

Start: February 2017

A Study to Evaluate Safety, Tolerability, and Distribution of a Microdose of Radiolabeled BIIB067 (99mTc-MAG3-BIIB067) Co-administered With BIIB067 to Healthy Adults

The primary objective of the study is to evaluate the distribution in the central nervous system (CNS) of a microdose 99mTc-MAG3-BIIB067 co-administered with unlabeled BIIB067. The secondary objective of the study is to assess the safety and tolerability of unlabeled BIIB067 co-administered with a microdose of 99mTc-MAG3-BIIB067 to healthy participants.

Start: December 2018

Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.

Start: April 2021

First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes

The purpose of this study is to investigate how safe, and how well tolerated, the new study drug NNC0480-0389 is when it is given together with semaglutide. This will be investigated in healthy participants, participants with high bodyweight and participants with type 2 diabetes (T2D). NNC0480-0389 has not been given to humans before. It has been previously tested in the laboratory and on animals. NNC0480-0389 will be tested at various dose levels. Semaglutide is a new approved drug and is already available on the market for treatment of diabetes. It will also be investigated how quickly and to what extent NNC0480-0389 and semaglutide are taken up and eliminated from the body. This is called pharmacokinetics. The effect of NNC0480-0389 given together with semaglutide will also be investigated on body weight and glucose levels in the blood. This is called pharmacodynamics. The effects of NNC0480-0389 and/or semaglutide will be compared to the effects of a placebo. A placebo is a "dummy" medicine without any active medicine. Placebo looks like NNC0480-0389 and/or semaglutide. There are 4 possibilities for which treatment participants will get; participants will receive NNC0480-0389 and semaglutide or NNC0480-0389 and placebo or placebo with semaglutide, or placebo with placebo. Participants and the responsible doctor will not know which combination participants will be given. This is called a double-blinded study. However, this information can be looked up during the study if it is important for participants' health. The study medicines will be given as injections under the skin. Participants will be in the study for about 25 weeks.

Start: February 2020

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous doses of ASP5354 in healthy, adult Japanese male participants.

Start: May 2021

Inosine Energy Expenditure Study

Investigators want to test whether the intake of the nucleoside inosine increases the human energy expenditure. Inosine occurs as a metabolic intermediate in the human body and is sometimes taken as a dietary supplement by athletes. For this purpose, investigators will measure the basal metabolic rate by indirect calorimetry. Study participants will then take inosine dissolved in water or placebo and energy expenditure will be assessed again.

Start: June 2021

Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV[Delta]G-ZEBOV-GP) for Pre-Exposure Prophylaxis (PREP) in People at Potential Occupational Risk for Ebola Virus Exposure

Background: The Ebola virus causes a severe disease. It can be fatal. The usual incubation period after being exposed is 2 to 21 days. There is no approved treatment for Ebola infection. There is also no vaccine to prevent infection either before or after exposure. Researchers want to test an Ebola vaccine. They want to give it to people before they are exposed to the virus in order to prevent the disease. Objectives: To see how long-lasting and effective the vaccine rVSV[delta]G ZEBOV-GP (V920) is at preventing Ebola. Eligibility: Healthy adults at risk of exposure to the Ebola virus at work through lab or clinical contact. Design: Participants will be screened with medical history, physical exam, and blood tests. Participants will get the study vaccine. It will be injected into their upper arm. Participants will be monitored closely for at least 30 minutes. They will get a diary card to record any symptoms they have from the vaccine for up to 14 days. Participants will have study visits at 1, 3, and 6 months after they get the vaccine, then every 6 months (that is, at months 12, 18, 19, 24, 30, and 36 of study) for a total of 36 months. Eighteen months after they join the study, participants will be randomly assigned to one of two groups. One group will get a second (or booster ) dose of the vaccine. The other group will not get a second dose. This study lasts 36 months.

Start: October 2016

Bioequivalence Study Between Capoten Versus Captopril Reference Product in Healthy Adult Participants Under Fasting Conditions

This is a bioequivalence study to compare Capoten (test product [T]) versus captopril (reference product [R]) produced by Mylan Pharmaceuticals Spain, in healthy adult participants under fasting condition. Capoten is the registered trademark of SmithKline Beecham Egypt.

Start: June 2021

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry.

This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of single ascending doses (SAD) of AZD2373 in healthy male subjects of African ancestry.

Start: February 2020