View clinical trials related to Healthy Volunteers.
Filter by:This study will investigate the PK, relative bioavailability, safety, and tolerability of the extended release (ER) 50 mg MN-166 (ibudilast) tablet formulation as compared to the intermediate-release (IR) capsule formulation of MN-166 (ibudilast) and to examine the effect of food on the pharmacokinetics of the ER formulation.
This study is an in-house feasibility study of penicillin biosensor technology linked with closed-loop control for the automated delivery of penicillin antibiotics.
This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of cenerimod following a single dose in healthy Japanese and Caucasian participants. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body. There will be 2 groups in the study. 10 Japanese participants in one group and 10 Caucasian participants in the other group. The duration of participation in this study is approximately 75 days from screening to the end of study visit. A screening visit is required within 21 days prior to the start of the study to determine whether the volunteer qualifies and is willing to participate in this research study. This study requires in-patient stay in the research clinic of 4 days (3 nights) followed by outpatient visits and an end of study visit 3 to 5 days after the day 49 outpatient visit.
This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a single dose.
Calorie restriction (CR), which has the potential effect on weight loss and blood amino acids, has been demonstrated to associate with gut microbiota in humans, especially in obese individuals. However, studies for simultaneously evaluating enterotype-dependent impacts of CR on the gut microbiota and blood amino acids in nonobese individuals are still limited. Here, 41 nonobese individuals received a 3-week CR diet with approximately 50% fewer calories than a normal diet. The investigators measured individuals' BMI and blood amino acid concentration, along with the gut microbiota before and after the intervention. In this trial, 28 Enterotype Bacteroides (ETB) subjects and 13 Enterotype Prevotella (ETP) subjects were identified before the intervention. The purpose of this intervention study is to evaluate the effect of calorie restriction on BMI loss, amino acid, and gut microbiota in healthy volunteers of two different enterotypes and provide useful insights for potential application of gut microbiome stratification in personalized nutrition intervention.
Background: Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990, as it is known to improve physical performance. Hypothesis: The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows obtaining positive doping samples. The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum. Objectives: Primary objective: To generate enough serum samples positive to recombinant somatropin in order to be analyzed as control samples by anti-doping laboratories. Secondary objective: To determine the analytical parameters necessary to detect the administration of recombinant somatropin in healthy volunteers by direct and/or indirect methods. Methods: Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study correspond to basal samples of 2 subjects who do not receive any treatment.
Depending on the point of view, different definitions of aging have been proposed. Thus, at the biological level, aging corresponds to a natural physiological process that leads to the progressive degeneration of cells and the slowing down of the vital functions of a living organism. More generally, aging is a multifactorial and multidimensional process that occurs at the cognitive, social, biological or psychological level. The primary objective of this study is to evaluate the balance between activation (Task-Positive Network : TPN-Language, L, TPN-Verticality, V) and rest (Task-Negative Network : TNN) activity during normal aging, in two domains (language and posturo-spatial perception of verticality).
The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination
This investigator initiated, pilot study will assess the feasibility of characterizing the effects of an orally administered alpha-2 adrenergic (a2a) agonist, clonidine, on the clearance rates of Carbon-11 butanol from the ventricular cerebrospinal fluid (vCSF) with positron emission tomography (PET) in healthy volunteers.
Background: Vaccines help prevent disease by causing the body to have an immune response. Many parts of this response happen in the blood. This response happens over days and weeks after getting the vaccine. Researchers want to how the blood changes over time in response to vaccines. They want to find out why vaccines work better for some people than for others. This could help make more effective vaccines. Objective: To learn about how the body responds to vaccines. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Participants will have 9 visits over 6 months. All visits will include blood tests and a physical exam. Participants will have the first visit 1 week before they get the vaccine. Participants will get the flu vaccine at the second visit. The vaccine will be injected into the muscle of the upper arm with a needle. They will be watched for side effects for 15 minutes. Participants will have the next 2 visits exactly 1 day and 1 week after they get the vaccine. They will have the other 5 visits about 14, 28, 70, and 100 days after they get the vaccine. Participants will take email questionnaires about whether they had any side effects. Participants may have optional extra study visits. These will be no more than once a month for up to 1 year after they get the vaccine. Optionally, they can also repeat the study each year through the 2023 - 2024 flu season