View clinical trials related to Healthy Volunteers.
Filter by:Pharmacokinetics, pharmacodynamics and tolerability of AOP200704 infusion is compared to that of Esmolol by measurement of plasma concentrations of AOP200704, esmolol and their metabolites, by assessing the effect of both drugs on dobutamine-induced tachycardia, and by monitoring vital signs, ECG and adverse events.
This project is a pilot safety and immunogenicity study of transcutaneous vaccination with live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin. Transcutaneous vaccination is needle-less application of materials directly to the skin. Healthy adult volunteers (4 per group) will receive either: - Saline (placebo) - Cholera toxin adjuvant alone - L. monocytogenes BMB72 bacteria alone - L. monocytogenes BMB72 bacteria plus Cholera toxin adjuvant Vaccine solutions will be applied to the upper deltoid area under a standard Tegaderm dressing. Key primary endpoints include: safety as measured primarily by clinical findings (VS, cutaneous exams, and systemic reactions), and immune responses as measured by serological responses to L. monocytogenes, influenza A nucleoprotein, CT, and IFN gamma ELISPOT responses to listeriolysin and nucleoprotein peptides. Local skin immune responses will be evaluated by skin biopsy in subjects who agree to that (optional). The study will begin with 2 "roll-in" subjects receiving both L. monocytogenes and CT.
The purpose of this study is to investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.
The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants.
The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50 mg tablets in healthy human adult male subjects under fasting conditions.
Vaccines induce protective immunity against numerous infectious diseases. However, current vaccines have limited efficacy against challenging infections like tuberculosis, malaria, and HIV. Protein vaccines are safe but, typically they induce weak T cell immunity when administered alone. Therefore, special attention is being given to adjuvants, which are enhancers of immunity, that cab mature antigen presenting immunostimulatory dendritic cells. Our goal is to study in humans the mechanism whereby a synthetic adjuvant, poly ICLC, which acts on defined pattern recognition receptors, enhances T an B cell immunity. In preclinical studies, our lab has found in mice that poly IC and its analog poly ICLC are superior adjuvants for T cell mediated immunity relative to other agonists for PRR. Poly ICLC has been extensively studied in humans with a favorable safety profile. In a recently completed Phase I study, poly ICLC was found to be safe and well tolerated when administered as a single dose of 1.6 mg subcutaneously and intranasally to healthy volunteers. In additional, preliminary data shows marked upregulation of gene expression in whole PBMSc following s.c. injection of poly ICLC as well as activation of various blood cell type, including dendritic cells and monocytes. In this study the investigators propose to extend the evaluation of innate immune responses following s.d. injection of poly ICLC to healthy volunteers. The investigators propose to characterize poly ICLC effects on specific blood cell types, focusing on three different subsets of DC's, by analyzing gene transcriptional changes at baseline and at one day following its administration. In order to study the early local effects of poly ICLC, which are important for the recruitment and activation of antigen presenting cells, the investigators also propose to perform skin biopsies at a skin site contralateral to the injection site and at the injection site after poly ICLC injections.
This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50, mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will receive a single study injection of either mipomersen or placebo. Subjects will be enrolled into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design. Dose-escalation will proceed only if there is an acceptable safety profile from the previous dosing level.
This is a single dose study of radio-labeled [14C]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104. This study requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes only and is not intended to treat any medical condition.
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
The objective of this study is to determine the effect of multiple doses of mirabegron on the pharmacokinetics of an oral contraceptive.