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PubMed Journals Articles About "A Phase 1 Study In Healthy Volunteers For AL101" RSS

18:58 EST 27th January 2020 | BioPortfolio

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Showing "Phase Study Healthy Volunteers AL101" PubMed Articles 1–25 of 67,000+

Long-term safety and vaccine-induced seropositivity in healthy volunteers from HIV vaccine trials: a French cohort study.

The ANRS COV1-COHVAC cohort was a long-term safety cohort of healthy volunteers who received preventive HIV-vaccine candidates in 17 phase I/II clinical trials.


'Becoming-with' a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials.

Recent sociological research has raised important sociological and ethical questions about the role of financial rewards in terms of healthy volunteer involvement in clinical trials. Research suggests that it would be parochial to assume financial rewards alone are sufficient to explain repeat healthy volunteering. This paper explores other factors that might explain repeat healthy volunteering behaviours in phase I clinical drug trials. Drawing on qualitative research with healthy volunteers, the paper arg...

Why Knowing Healthy Controls Matters.

Although healthy volunteers often serve as controls or primary participants in neuroscience research, they are usually less rigorously screened than patients, which can have far-reaching implications for interpretation of study results. Although this issue has long been recognized, it is rarely discussed in the research literature. This article examines how the rigorous screening and characterization of healthy volunteers is key for quality research.


The influence of gastric motility on the intraluminal behavior of fosamprenavir.

In fasting conditions, the gastrointestinal system contracts according to the interdigestive migrating motor complex (MMC), in which phases of quiescence (MMC phase I) alternate phases of medium (MMC phase II) to very strong (MMC phase III) contractions. The time of drug intake relative to this cyclic motility pattern may cause variations in formulation behavior. To explore this hypothesis, a cross-over study was performed in healthy volunteers with an immediate release tablet of fosamprenavir (Telzir) whic...

UPLC-MS/MS method for gemfibrozil determination in plasma with application to a pharmacokinetic study in healthy Brazilian volunteers.

Gemfibrozil (GFZ) is a derivative of fibric acid and is used in the treatment of dyslipidemia. GFZ may affect the metabolism of various drugs, including statins, by inhibiting the sinusoidal influx transporter OATP1B1 and also CYP2C9 and CYP2C8 enzymes. This study presents the development and validation of a rapid, simple, sensitive and reproducible method of GFZ analysis in human plasma using UPLC-MS/MS. The method was applied in a pharmacokinetic study following administration of multiple doses of 600 m...

Phase 1 study of crisaborole in Japanese healthy volunteers and patients with atopic dermatitis.

Crisaborole ointment, 2%, is a non-steroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD). This parallel-cohort, phase 1 study was conducted to investigate skin irritation potential and safety of crisaborole in healthy Japanese adults (cohort 1) and the safety and pharmacokinetic profile of crisaborole and metabolites AN7602 and AN8323 in Japanese adults with mild to moderate AD (cohort 2). In cohort 1, 20 healthy volunteers received single applications of crisa...

Increased systemic endothelial-dependent microvascular reactivity after ingestion of a high-carbohydrate snack in young, healthy volunteers.

This study evaluated the acute effect of a high-carbohydrate snack (HCS) on systemic microvascular function of healthy, young volunteers, using laser speckle contrast imaging (LSCI).

The viewing of a 'Bloodcurdling' horror movie increases platelet reactivity: A randomized cross-over study in healthy volunteers.

Epidemiological studies have suggested an increased risk of cardiovascular events (CVE) during acute stressful and/or frightful moments. A possible explanation for this could be an effect of acute stress on hemostasis. A recent study demonstrated an increase in factor VIII after watching a horror movie. Primary hemostasis, however, is thought to play a more prominent role in the etiology of CVE. The objective of this study was therefore to assess the influence of viewing a 'bloodcurdling' horror movie on pl...

Early and late effects of remote ischemic preconditioning on spirometry and gas exchange in healthy volunteers.

Remote ischemic preconditioning (RIP) may protect remote organs from ischemia-reperfusion-injury (IRI) in surgical and non-surgical patients. There are few data available on RIP and lung function, especially not in healthy volunteers. The null-hypothesis was tested that RIP does not have an effect on pulmonary function when applied on healthy volunteers that were breathing spontaneously and did not experience any intervention. After approval of the Ethics Committee and informed consent of the study subjects...

Healthy Aging and Cardiovascular Function: Invasive Hemodynamics During Rest and Exercise in 104 Healthy Volunteers.

The aim of this study was to evaluate the association between age and invasive cardiovascular hemodynamics during upright exercise among healthy adults.

The gut microbiome in epilepsy.

The close relationship between epilepsy and autoimmune diseases and the fact that the cause of epilepsy is idiopathic in 60% of cases suggest that intestinal microbiota may play a role in the etiology of epilepsy. In this study, we analyzed and compared the intestinal microbiota composition of patients with idiopathic focal epilepsy (n = 30) and healthy volunteer group (n = 10) by 16s ribosomal DNA sequencing. Proteobacteria phylum was found to be higher in patients with epilepsy (25.4%) than in hea...

Effect of pituitary adenylate cyclase-activating polypeptide-27 on cerebral hemodynamics in healthy volunteers: a 3T MRI study.

Pituitary adenylate cyclase-activating polypeptide (PACAP) has emerged as an important signaling peptide in migraine pathogenesis. Recently, we have shown that the less-abundant PACAP isoform, PACAP27, induced migraine and headache in patients equipotently to PACAP38. The present study examined the effect of PACAP27 on cerebral hemodynamics in healthy volunteers using high resolution magnetic resonance angiography (MRA). Eighteen healthy volunteers received infusion of PACAP27 (10 pmol/kg/min) or placebo ...

A phase 1 antigen dose escalation trial to evaluate safety, tolerability and immunogenicity of the leprosy vaccine candidate LepVax (LEP-F1 + GLA-SE) in healthy adults.

Healthy United States-based adult volunteers with no history of travel to leprosy-endemic countries were enrolled for the first-in-human evaluation of LepVax (LEP-F1 + GLA-SE). In total 24 volunteers participated in an open-labelclinicaltrial, with 21 receiving three injections of LepVax consisting of either 2 µg or 10 µg recombinantpolyprotein LEP-F1 mixed with 5 µg of the GLA-SE adjuvant formulation. LepVax doses were provided by intramuscular injection on Days 0, 28, and 56, and safety was evalua...

Oral ferroportin inhibitor VIT-2763: first-in-human, Phase 1 study in healthy volunteers.

Restriction of iron availability by ferroportin inhibition is a novel approach to treating non-transfusion-dependent thalassemia (β-thalassemia intermedia). This first-in-human, Phase I study (https://www.clinicaltrialsregister.eu; EudraCT no. 2017-003395-31) assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses (SAD and MAD) of the oral ferroportin inhibitor, VIT-2763, in healthy volunteers. Participants received VIT-2763 5/15/60/120/240 mg or pla...

Using of ¹⁸F-FDG to evaluate the effect of traumatic olfactory nerve injury on drug delivery through the nasal-brain pathway: a PET-MRI pilot study.

This study evaluated the effect of traumatic olfactory nerve injury on drug delivery through the nasal-brain pathway via the instillation of ¹⁸F-FDG at the olfactory cleft. Seven healthy volunteers and 5 patients with traumatic dysosmia were enrolled in the study. Subjects were all instilled with ¹⁸F-FDG on each side of the olfactory cleft under endoscopy. After 12 hours, a PET/MR scan was performed to track the metabolism pathway of ¹⁸F-FDG. Then, we compared the diameter of the olfactory bulb and...

A phase 1/1b study of PUR1900, an inhaled formulation of itraconazole, in healthy volunteers and asthmatics to study safety, tolerability and pharmacokinetics.

Oral itraconazole has variable pharmacokinetics and risks of adverse events (AEs) associated with high plasma exposure. An inhalation formulation of itraconazole (PUR1900) is being developed to treat Allergic Bronchopulmonary Aspergillosis (ABPA), an allergic inflammatory disease occurring in asthmatics and patients with cystic fibrosis.

Examination of the effects of a new compression garment on skin tissue oxygenation in healthy volunteers.

Compression devices have been shown to reduce venous stasis, increase blood flow and skin tissue oxygenation (StO), promoting healthy tissue. This study aimed to explore the efficacy of a new compression garment in three different positions in healthy adults.

The potential application of human PIG-A assay on Azathioprine treated inflammatory bowel disease patients.

The rodent Pig-a assay has been used extensively as a potential regulatory assay for evaluating the in vivo mutagenicity of test substances. Although the assay can be conducted in different mammalian species, there have been only a few reports describing its use in humans, and rarely in genotoxicant-exposed human populations. In this study, PIG-A mutation frequencies (MFs) were evaluated in 36 Azathioprine (AZA) (human carcinogen) treated inflammatory bowel disease (IBD) patients and 36 healthy volunteers. ...

Effect of hot arm and foot bath on heart rate variability and blood pressure in healthy volunteers.

Background Though hot arm and foot bath (HAFB) is widely used, a precise physiological response is not reported. Hence, the present study was conducted to evaluate the effect of HAFB on heart rate variability (HRV) and blood pressure (BP) in healthy volunteers. Materials and Methods Sixteen healthy male volunteers' aged 23.81 ± 5.27 (mean ± standard deviation) years were recruited. All the subjects underwent only one session of HAFB (104-degree Fahrenheit) for the duration of 20 min. Assessments...

DNL104, a centrally penetrant RIPK1 inhibitor, inhibits RIP1 kinase phosphorylation in a randomized phase I ascending dose study in healthy volunteers.

RIP kinase 1 regulates inflammation, cytokine release, and necroptotic cell death and is implicated in pathogenic cellular pathways in ALS, AD and MS. Inhibition of RIPK1 activity protects against inflammation and cell death in multiple animal models. DNL104 is a selective, brain-penetrant inhibitor of RIPK1 phosphorylation in clinical development for AD and ALS. DNL104 was tested in 68 healthy volunteers to investigate safety and tolerability, pharmacokinetic profile in plasma and CSF, and pharmacodynamic ...

An improved LC-MS/MS method for determination of cinacalcet in human plasma and its application to the evaluation of food intake effect on the pharmacokinetics of cinacalcet in healthy volunteers.

A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of cinacalcet in human plasma was developed and validated. This assay was based on the liquid-liquid extraction and cinacalcet-d4 was used as an internal standard (IS). Separation was achieved on a C18 column by the mobile phase A of water (containing 0.1% formic acid) and the mobile phase B of acetonitrile - water (95:5, V/V) (containing 0.2% formic acid) with the gradient elution. Quantification was done using multipl...

Safety, pharmacokinetic and pharmacodynamic properties of single ascending dose and continuous infusion of remimazolam besylate in healthy Chinese volunteers.

The aim of the present study was to evaluate the safety, pharmacokinetic (PK) and pharmacodynamic (PD) properties of remimazolam besylate following single ascending dose (SAD) and continuous infusion in healthy Chinese volunteers.

Determining real change in conditioned pain modulation: a repeated measures study in healthy volunteers.

Conditioned pain modulation (CPM) is a potentially useful biomarker in pain populations; however, a statistically robust interpretation of change scores is required. Currently, reporting of CPM does not consider measurement error. Hence, the magnitude of change representing a "true" CPM effect is unknown. This study determined the standard error of measurement (SEM) and proportion of healthy participants showing a 'true' CPM effect with a standard CPM paradigm. Fifty healthy volunteers participated in an in...

Markers of systemic inflammation in response to osmotic stimulus in healthy volunteers.

Hyperosmolality, osmotic stimulus or stress results in vasopressin release. Animal and human in vitro studies have shown that inflammatory parameters such as interleukin-8 (IL-8) and tumour necrosis factor-α (TNF-α) increase in parallel in the central nervous system and bronchial, corneal or intestinal epithelial cell lines in response to osmotic stimulus. Whether osmotic stimulus directly causes a systemic inflammatory response in humans is unknown. We therefore investigated the influence of osmotic stim...

Cefuroxime pharmacokinetics and pharmacodynamics for intravenous dosage regimens with 750 mg or 1500 mg doses in healthy young volunteers.

Cefuroxime is an important antibiotic to treat several serious infections. Rapid elimination through the kidneys and the variation in MICs of various susceptible pathogens such as and give rise to dosing issues, especially in otherwise healthy patients. To investigate the probability of target attainment (PTA) for obtaining the optimal dosage regimens for cefuroxime in healthy young people. Two weeks apart 750 and 1500 mg cefuroxime were administered as an intravenous bolus to 20 healthy volunteers (mea...


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