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https://www.readbyqxmd.com/read/28537452/safety-and-effectiveness-of-longer-focal-beam-and-burst-duration-in-ultrasonic-propulsion-for-repositioning-urinary-stones-and-fragments
#1
Karmon Janssen, Timothy C Brand, Bryan W Cunitz, Yak-Nam Wang, Julianna Simon, Frank Starr, H Denny Liggitt, Jeff Thiel, Mathew D Sorensen, Jonathan D Harper, Michael R Bailey, Barbrina Dunmire
PURPOSE: In the first-in-human trial of ultrasonic propulsion, subjects passed collections of residual stone fragments repositioned with a C5-2 probe. Here, effectiveness and safety in moving multiple fragments is compared between the C5-2 and a custom (SC-50) probe that produces a longer focal beam and burst duration. MATERIAL AND METHODS: Effectiveness was quantified by the number of stones expelled from a calyx phantom consisting of a 30-mm deep, water-filled well in a block of tissue mimicking material...
May 24, 2017: Journal of Endourology
https://www.readbyqxmd.com/read/28531827/safety-and-performance-of-the-second-generation-enlightn%C3%A2-renal-denervation-system-in-patients-with-drug-resistant-uncontrolled-hypertension
#2
Stephen G Worthley, Gerard T Wilkins, Mark W Webster, Joseph K Montarello, Sinny Delacroix, Robert J Whitbourn, Roderic J Warren
BACKGROUND AND AIMS: Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and performance of the second generation EnligHTN™ Renal Denervation System. METHODS: This first-in-human, prospective, multi-center, non-randomized study included 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mmHg) with drug-resistant hypertension...
May 3, 2017: Atherosclerosis
https://www.readbyqxmd.com/read/28523582/first-in-human-radiation-dosimetry-of-68-ga-nodaga-rgdyk
#3
Silvano Gnesin, Periklis Mitsakis, Francesco Cicone, Emmanuel Deshayes, Vincent Dunet, Augusto F Gallino, Marek Kosinski, Sébastien Baechler, Franz Buchegger, David Viertl, John O Prior
BACKGROUND: Integrin-targeting radiopharmaceuticals have potential broad applications, spanning from cancer theranostics to cardiovascular diseases. We have previously reported preclinical dosimetry results of (68)Ga-NODAGA-RGDyK in mice. This study presents the first human dosimetry of (68)Ga-NODAGA-RGDyK in the five consecutive patients included in a clinical imaging protocol of carotid atherosclerotic plaques. Five male patients underwent whole-body time-of-flight (TOF) PET/CT scans 10, 60 and 120 min after tracer injection (200 MBq)...
December 2017: EJNMMI Research
https://www.readbyqxmd.com/read/28516358/mechanistic-modeling-of-the-pharmacodynamic-and-pharmacokinetic-relationship-of-tissue-factor-pathway-inhibitor-neutralizing-antibody-bay-1093884-in-cynomolgus-monkeys
#4
Jian-Ming Gu, Xiao-Yan Zhao, Thomas Schwarz, Joachim Schuhmacher, Andreas Baumann, Elena Ho, Babu Subramanyan, Kathy Tran, Timothy Myles, Chandra Patel, Maria Koellnberger
BAY 1093884 is a fully human monoclonal antibody against the tissue factor pathway inhibitor (TFPI) in development as prophylaxis in patients with hemophilia with or without inhibitors. In vitro, BAY 1093884 binds to human, mouse, and monkey TFPI. The objective of this study was to find a pharmacodynamic (PD) biomarker after administration of BAY 1093884 to normal monkeys. In monkey plasma, BAY 1093884 exhibited an IC50 (concentration that inhibits 50%) of 4.65 and 6.19 nM for free TFPI and diluted prothrombin time (dPT), respectively...
May 17, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28514206/first-in-human-pet-ct-imaging-of-metastatic-neuroendocrine-neoplasms-with-cyclotron-produced-44-sc-dotatoc-a-proof-of-concept-study
#5
Aviral Singh, Nicholas P van der Meulen, Cristina Müller, Ingo Klette, Harshad R Kulkarni, Andreas Türler, Roger Schibli, Richard P Baum
(44)Sc is a promising positron emission tomography (PET) radionuclide (T1/2 = 4.04 hours, Eβ+average = 632 keV) and can be made available, using a cyclotron production route, in substantial quantities as a highly pure product. Herein, the authors report on a first-in-human PET/CT study using (44)Sc-DOTATOC prepared with cyclotron-produced (44)Sc. The production of (44)Sc was carried out through the (44)Ca(p,n)(44)Sc nuclear reaction at Paul Scherrer Institut, Switzerland. After separation, (44)Sc was shipped to Zentralklinik Bad Berka, Germany, where radiolabeling was performed, yielding radiochemically pure (44)Sc-DOTATOC...
May 2017: Cancer Biotherapy & Radiopharmaceuticals
https://www.readbyqxmd.com/read/28504218/first-in-human-evaluation-of-a-novel-poly-l-lactide-based-sirolimus-eluting-bioresorbable-vascular-scaffold-for-the-treatment-of-de-novo-native-coronary-artery-lesions-meres-1-trial
#6
Ashok Seth, Yoshinobu Onuma, Ricardo Costa, Praveen Chandra, Vinay K Bahl, Cholenahally N Manjunath, Ajaykumar U Mahajan, Viveka Kumar, Pravin K Goel, Gurpreet S Wander, Mathew S Kalarickal, Upendra Kaul, V K Ajit Kumar, Pratap C Rath, Vijay Trehan, Gunasekaran Sengottuvelu, Sundeep Mishra, Alexandre Abizaid, Patrick W Serruys
AIMS: The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold (MeRes100 BRS) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities. METHODS AND RESULTS: The MeRes-1 first-in-human trial was a single-arm, prospective, multicentre study, which enrolled 108 patients with de novo coronary artery lesions (116 scaffolds were deployed to treat 116 lesions in 108 patients)...
May 16, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28498840/a-third-generation-vaccine-for-human-visceral-leishmaniasis-and-post-kala-azar-dermal-leishmaniasis-first-in-human-trial-of-chad63-kh
#7
Mohamed Osman, Anoop Mistry, Ada Keding, Rhian Gabe, Elizabeth Cook, Sarah Forrester, Rebecca Wiggins, Stefania Di Marco, Stefano Colloca, Loredana Siani, Riccardo Cortese, Deborah F Smith, Toni Aebischer, Paul M Kaye, Charles J Lacey
BACKGROUND: Visceral leishmaniasis (VL or kala azar) is the most serious form of human leishmaniasis, responsible for over 20,000 deaths annually, and post kala azar dermal leishmaniasis (PKDL) is a stigmatizing skin condition that often occurs in patients after successful treatment for VL. Lack of effective or appropriately targeted cell mediated immunity, including CD8+ T cell responses, underlies the progression of VL and progression to PKDL, and can limit the therapeutic efficacy of anti-leishmanial drugs...
May 12, 2017: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/28495397/safety-profile-and-long-term-engraftment-of-human-cd31-blood-progenitors-in-bone-tissue-engineering
#8
Hadar Zigdon-Giladi, Rina Elimelech, Gal Michaeli-Geller, Utai Rudich, Eli E Machtei
BACKGROUND: Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering. METHODS: hEPCs were isolated from peripheral blood, cultured and characterized...
May 8, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28490463/a-first-in-human-phase-i-dose-escalation-study-of-tak-117-a-selective-pi3k-alpha-isoform-inhibitor-in-patients-with-advanced-solid-malignancies
#9
Dejan Juric, Johann S de Bono, Patricia M LoRusso, John Nemunaitis, Elisabeth I Heath, Eunice L Kwak, Teresa Macarulla Mercadé, Elena Geuna, Maria Jose de Miguel-Luken, Chirag Patel, Keisuke Kuida, Serap Sankoh, Eric H Westin, Fabian Zohren, Yaping Shou, Josep Tabernero
Purpose: To evaluate the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of TAK-117 (MLN1117/INK1117), an investigational PI3Kα-selective inhibitor, in patients with advanced solid tumors. <p>Experimental Design: Seventy-one patients received oral TAK-117 once daily (QD, 100-300 mg [n = 24]), or 3 days per week (Mon-Wed-Fri [MWF], 200-1200 mg [n = 27]; Mon-Tue-Wed [MTuW], 200-900 mg [n = 20]), in 21-day cycles. Dose escalation proceeded via a 3+3 design...
May 10, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28488350/cranial-reconstruction-using-allogeneic-mesenchymal-stromal-cells-a-phase-1-first-in-human-trial
#10
David Anthony Morrison, Alan Matthew Kop, Anastasia Nilasaroya, Marian Sturm, Kathryn Shaw, Stephen Honeybul
Cranioplasty is necessary for patients that have undergone craniectomy following trauma, stroke or other causes of elevated intracranial pressure. This study assessed the effectiveness of treating cranial defects with a combination of allogeneic mesenchymal stromal cells (MSC) on a ceramic carrier and polymer scaffold, to produce viable bone and healing of a cranial void. Patients underwent a baseline CT scan for construct design. Two sets of interlocking moulds were 3D-printed to enable shaping of two polymer meshes which formed the boundaries of the construct corresponding to restoration of the skull interna and externa...
May 9, 2017: Journal of Tissue Engineering and Regenerative Medicine
https://www.readbyqxmd.com/read/28488306/physician-initiated-first-in-human-clinical-study-using-a-novel-angiogenic-peptide-ag30-5c-for-patients-with-severe-limb-ulcers
#11
Hironori Nakagami, Toshifumi Yamaoka, Misa Hayashi, Atsushi Tanemura, Yasushi Takeya, Hitomi Kurinami, Ken Sugimoto, Ayumi Nakamura, Kazunori Tomono, Katsuto Tamai, Ichiro Katayama, Hiromi Rakugi, Yasufumi Kaneda
AIM: In patients with diabetes or ischemia, angiogenesis and infection control are required for chronic leg ulcers, which substantially impair patients' quality of life. We developed a novel functional peptide, named AG30/5C, with angiogenic and anti-microbial properties. Treatment with AG30/5C significantly accelerated the wound healing of full-thickness defects in mice. To evaluate the safety of AG30/5C in the treatment of leg ulcers, a physician-initiated clinical study was carried out...
May 10, 2017: Geriatrics & Gerontology International
https://www.readbyqxmd.com/read/28483710/current-nonclinical-testing-paradigms-in-support-of-safe-clinical-trials-an-iq-consortium-drusafe-perspective
#12
Lynne D Butler, Peggy Guzzie-Peck, James Hartke, Matthew S Bogdanffy, Yvonne Will, Dolores Diaz, Elisabeth Mortimer-Cassen, Mazin Derzi, Nigel Greene, Joseph J DeGeorge
The transition from nonclinical to First-in-Human (FIH) testing is one of the most challenging steps in drug development. In response to serious outcomes in a recent Phase 1 trial (sponsored by Bial), IQ Consortium/DruSafe member companies reviewed their nonclinical approach to progress small molecules safely to FIH trials. As a common practice, safety evaluation begins with target selection and continues through iterative in silico and in vitro screening to identify molecules with increased probability of acceptable in vivo safety profiles...
May 5, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28481116/overcoming-the-road-blocks-advancement-of-block-copolymer-micelles-for-cancer-therapy-in-the-clinic
#13
Loujin Houdaihed, James C Evans, Christine Allen
With countless preclinical studies on block copolymer micelles (BCMs) successfully demonstrating the superiority of these advanced drug delivery formulations over conventional formulations, it remains somehow discouraging that only a few have reached clinical evaluation and practice. With a critical eye, this review aims to compare and summarize the preclinical and clinical data available on several BCM formulations and to identify their primary role in drug delivery as "carrier" or "solubilizer". This review focuses on polymeric micelles that have reached clinical evaluation and/or are being pursued commercially...
May 18, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28479852/a-first-in-human-double-blind-placebo-controlled-randomized-dose-escalation-study-of-dwp05195-a-novel-trpv1-antagonist-in-healthy-volunteers
#14
Jieon Lee, Bo-Hyung Kim, Kyung-Sang Yu, Hee Sun Kim, Ji Duck Kim, Joo-Youn Cho, SeungHwan Lee, Namyi Gu
OBJECTIVES: DWP05195 is a transient receptor potential vanilloid 1 (TRPV1) antagonist developed for managing pain. The purpose of this study was to evaluate the pharmacodynamics pharmacokinetics, safety, and tolerability of DWP05195 in healthy subjects. This was a first-in-human randomized, double-blinded, placebo-controlled, dose escalation study. SUBJECTS AND METHODS: DWP05195 or placebo was administered as a single dose of 10-600 mg in the single-dose study and as 100-400 mg once daily for 8 days in the multiple-dose studies...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28471046/a-first-in-human-evaluation-of-a-novel-contrast-media-saving-device
#15
James Sapontis, Garry Barron, Sujith Seneviratne, Georg Fuernau, Ingo Eitel, Jakob Ledwoch, Holger Thiele, Mohammed Saad, Suzanne de Waha, Janine Poess, Steffen Desch
OBJECTIVES: This study evaluated the usability and contrast volume savings of the novel DyeVert™ System. BACKGROUND: During coronary diagnostic and interventional procedures, a substantial portion of injected contrast does not contribute to vessel imaging due to reflux into the ascending aorta. Contrast volume is the primary physician modifiable risk factor for prevention of contrast-induced acute kidney injury CI-AKI which is a frequent complication in patients undergoing coronary angiographic procedures and is related to increases in morbidity, mortality, and healthcare costs...
May 4, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28465315/a-first-in-human-clinical-study-of-a-new-sp-b-and-sp-c-enriched-synthetic-surfactant-chf5633-in-preterm-babies-with-respiratory-distress-syndrome
#16
David G Sweet, Mark A Turner, Zbyněk Straňák, Richard Plavka, Paul Clarke, Ben J Stenson, Dominique Singer, Rangmar Goelz, Laura Fabbri, Guido Varoli, Annalisa Piccinno, Debora Santoro, Christian P Speer
OBJECTIVE: CHF5633 (Chiesi Farmaceutici S.p.A., Parma, Italy) is the first fully synthetic surfactant enriched by peptide analogues of two human surfactant proteins. We planned to assess safety and tolerability of CHF5633 and explore preliminary efficacy. DESIGN: Multicentre cohort study. PATIENTS: Forty infants from 27(+0) to 33(+6) weeks gestation with respiratory distress syndrome requiring fraction of inspired oxygen (FiO2) ≥0.35 were treated with a single dose of CHF5633 within 48 hours after birth...
May 2, 2017: Archives of Disease in Childhood. Fetal and Neonatal Edition
https://www.readbyqxmd.com/read/28464496/pharmacokinetics-safety-and-tolerability-following-single-and-multiple-doses-of-pibrentasvir-in-a-first-in-human-study
#17
Chih-Wei Lin, Sandeep Dutta, Armen Asatryan, Haoyu Wang, Jack Clifton, Andrew Campbell, Wei Liu
This first-in-human dose-ascending study investigated pharmacokinetics, safety, and tolerability of pibrentasvir following single and multiple doses in healthy volunteers. Additionally, the effects of food and ritonavir on pibrentasvir were assessed in a crossover study design. The starting dose of pibrentasvir was selected based on the no-observed-adverse-effect-level exposure from preclinical studies. Dose escalations of subsequent cohorts were dependent on reviews of the safety, tolerability, and pharmacokinetic data from previous dose cohorts...
May 2, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28464321/a-phase-1-study-to-assess-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-single-oral-doses-of-ds-3801b-a-motilin-receptor-agonist-in-healthy-subjects
#18
Justin Dennie, George Atiee, Vance Warren, Ben Tao, Kiyoshi Morimoto, Giorgio Senaldi
DS-3801b is an orally active, nonmacrolide, selective motilin receptor agonist. The aim of this 2-part first-in-human study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects on proximal and distal gastrointestinal (GI) motility of single oral doses of DS-3801b in healthy subjects. The (13) C-octanoate breath test was used to assess gastric emptying (GE), a measure of proximal GI motility. The time to first bowel movement (TTFBM) and the consistency of the first bowel movement according to the Bristol Stool Scale (BSS) were recorded to assess distal GI motility...
May 2, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28463630/safety-and-activity-of-varlilumab-a-novel-and-first-in-class-agonist-anti-cd27-antibody-in-patients-with-advanced-solid-tumors
#19
Howard A Burris, Jeffrey R Infante, Stephen M Ansell, John J Nemunaitis, Geoffrey R Weiss, Victor M Villalobos, Branimir I Sikic, Matthew H Taylor, Donald W Northfelt, William E Carson, Thomas R Hawthorne, Thomas A Davis, Michael J Yellin, Tibor Keler, Timothy Bullock
Purpose CD27, a costimulatory molecule on T cells, induces intracellular signals that mediate cellular activation, proliferation, effector function, and cell survival upon binding to its ligand, CD70. Varlilumab is a novel, first-in-class, agonist CD27 antibody that stimulates the CD27 pathway, which results in T-cell activation and antitumor activity in tumor models. This first-in-human, dose-escalation and expansion study evaluated the safety, pharmacology, and activity of varlilumab in patients with advanced solid tumors...
May 2, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28459733/a-phase-1-single-center-double-blind-placebo-controlled-study-in-healthy-subjects-to-assess-the-safety-tolerability-clinical-effects-and-pharmacokinetics-pharmacodynamics-of-intravenous-cyclopropyl-methoxycarbonylmetomidate-abp-700-after-a-single-ascending
#20
Michel M R F Struys, Beatrijs I Valk, Douglas J Eleveld, Anthony R Absalom, Peter Meyer, Sascha Meier, Izaak den Daas, Thomas Chou, Kai van Amsterdam, Jason A Campagna, Steven P Sweeney
BACKGROUND: Cyclopropyl-methoxycarbonylmetomidate (ABP-700) is a new "soft" etomidate analog. The primary objectives of this first-in-human study were to describe the safety and efficacy of ABP-700 and to determine its maximum tolerated dose. Secondary objectives were to characterize the pharmacokinetics of ABP-700 and its primary metabolite (cyclopropyl-methoxycarbonyl acid), to assess the clinical effects of ABP-700, and to investigate the dose-response and pharmacokinetic/pharmacodynamic relationships...
May 1, 2017: Anesthesiology
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