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#1
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Holden A, Merrilees S, Buckley B, et al. First-in-human experience with the Gore balloon-expandable covered endoprosthesis in iliac artery occlusive disease. J Endovasc Ther. 2017;24:11-18. doi: 10.1177/1526602816680570 .
April 2017: Journal of Endovascular Therapy
https://www.readbyqxmd.com/read/28331534/ford-and-edison-in-a-modern-regulatory-environment-the-first-in-human-trial-of-night-work-and-artificial-light
#2
EDITORIAL
Thomas C Erren, David M Shaw, Ursula Wild, J Valérie Groß
A thought experiment places Henry Ford and Thomas Alva Edison in a modern regulatory environment. In a utopian occupational world devoid of night-shifts or artificial light, Ford wants to experiment with "working through the night". To support Ford's project, Edison offers his patented electric lamps to "turn nights into days". An ethics committee [EC] does not approve the night-work experiment and Utopia's Food and Drug Administration [FDA] does not approve the potential medical device as safe for use by humans...
2017: Journal of Occupational Medicine and Toxicology
https://www.readbyqxmd.com/read/28331291/pharmacokinetics-and-tolerability-of-da-8031-a-novel-selective-serotonin-reuptake-inhibitor-for-premature-ejaculation-in-healthy-male-subjects
#3
Dongseong Shin, SeungHwan Lee, Sojeong Yi, Seo Hyun Yoon, Joo-Youn Cho, Mi Young Bahng, In-Jin Jang, Kyung-Sang Yu
OBJECTIVE: DA-8031 is a selective serotonin reuptake inhibitor under development for the treatment of premature ejaculation. This is the first-in-human study aimed at evaluating the pharmacokinetics and tolerability of DA-8031 and its metabolites (M1, M2, M4, and M5) in the plasma and urine after administration of a single oral dose in healthy male subjects. METHODS: A dose block-randomized, double-blind, placebo-controlled, single ascending dose study was conducted...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28331050/first-in-human-clinical-trial-of-oral-onc201-in-patients-with-refractory-solid-tumors
#4
Mark N Stein, Joseph R Bertino, Howard L Kaufman, Tina Mayer, Rebecca Moss, Ann Silk, Nancy Chan, Jyoti Malhotra, Lorna Rodriguez-Rodriguez, Joseph Aisner, Robert D Aiken, Bruce G Haffty, Robert S DiPaola, Tracie Saunders, Andrew Zloza, Sherri Damare, Yasmeen Beckett, Bangning Yu, Saltanat Najmi, Christian Gabel, Siobhan Dickerson, Ling Zheng, Wafik S El-Deiry, Joshua Allen, Martin Stogniew, Wolfgang Oster, Janice M Mehnert
Purpose ONC201 is a small molecule selective antagonist of the G protein-coupled receptor DRD2 that is the founding member of the imipridone class of compounds. A first-in-human phase I study of ONC201 was conducted to determine its recommended phase II dose (RP2D). Experimental Design This open-label study treated 10 patients during dose escalation with histologically-confirmed advanced solid tumors. Patients received ONC201 orally once every 3 weeks, defined as one cycle, at doses from 125 to 625 mg using an accelerated titration design...
March 22, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28328679/results-of-a-multicenter-prospective-pivotal-trial-of-the-first-inline-continuous-glucose-monitor-in-critically-ill-patients
#5
Grant V Bochicchio, Stan Nasraway, Laura Moore, Anthony Furnary, Eden Nohra, Kelly Bochicchio
INTRODUCTION: We have previously demonstrated that tight glycemic control (80-120 mg/dl) improves outcome in critically injured patients. However, many centers have gotten away from aggressive glucose control due to the workload and risk of hypoglycemia. The objective of this pivotal trial is to evaluate the first in human continuous inline glucose monitor (OptiScanner) in critically ill patients. METHODS: A multicenter pivotal trial was conducted over a 1 year period (2014-2015) at 4 major academic centers in 200 critically ill patients...
March 21, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28327200/a-first-in-human-phase-1-study-of-a-hepcidin-monoclonal-antibody-ly2787106-in-cancer-associated-anemia
#6
Saroj Vadhan-Raj, Rafat Abonour, Jonathan W Goldman, David A Smith, Christopher A Slapak, Robert L Ilaria, Ramon V Tiu, Xuejing Wang, Sophie Callies, Joanne Cox, Jay L Tuttle, Yiu-Keung Lau, Eric J Roeland
BACKGROUND: Hepcidin plays a central role in iron homeostasis and erythropoiesis. Neutralizing hepcidin with a monoclonal antibody (mAb) may prevent ferroportin internalization, restore iron efflux from cells, and allow transferrin-mediated iron transport to the bone marrow. This multicenter, phase 1 study evaluated the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of a fully humanized mAb (LY2787106) with high affinity for hepcidin in cancer patients with anemia...
March 21, 2017: Journal of Hematology & Oncology
https://www.readbyqxmd.com/read/28322043/-18-f-fluoro-hydroxyphenethylguanidines-efficient-synthesis-and-comparison-of-two-structural-isomers-as-radiotracers-of-cardiac-sympathetic-innervation
#7
Yong-Woon Jung, Keun Sam Jang, Guie Gu, Robert A Koeppe, Phillip S Sherman, Carole A Quesada, David M Raffel
Fluorine-18 labeled phenethylguanidines are currently under development in our laboratory as radiotracers for quantifying regional cardiac sympathetic nerve density using PET imaging techniques. In this study, we report an efficient synthesis of (18)F-hydroxyphenethylguanidines consisting of nucleophilic aromatic [(18)F]fluorination of a protected diaryliodonium salt precursor followed by a single deprotection step to afford the desired radiolabeled compound. This approach has been shown to reliably produce 4-[(18)F]fluoro-m-hydroxyphenethylguanidine ([(18)F]4F-MHPG, [(18)F]1) and its structural isomer 3-[(18)F]fluoro-p-hydroxyphenethylguanidine ([(18)F]3F-PHPG, [(18)F]2) with good radiochemical yields...
March 27, 2017: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/28319448/rationale-and-design-of-a-phase-1-clinical-trial-to-evaluate-hsv-g207-alone-or-with-a-single-radiation-dose-in-children-with-progressive-or-recurrent-malignant-supratentorial-brain-tumors
#8
Alicia M Waters, James M Johnston, Alyssa T Reddy, John Fiveash, Avi Madan-Swain, Kara Kachurak, Asim K Bag, G Yancey Gillespie, James M Markert, Gregory K Friedman
Primary central nervous system tumors are the most common solid neoplasm of childhood and the leading cause of cancer-related death in pediatric patients. Survival rates for children with malignant supratentorial brain tumors are poor despite aggressive treatment with combinations of surgery, radiation, and chemotherapy, and survivors often suffer from damaging lifelong sequelae from current therapies. Novel innovative treatments are greatly needed. One promising new approach is the use of a genetically engineered, conditionally replicating herpes simplex virus (HSV) that has shown tumor-specific tropism and potential efficacy in the treatment of malignant brain tumors...
March 2017: Human Gene Therapy. Clinical Development
https://www.readbyqxmd.com/read/28295451/ccl20-neutralisation-by-a-monoclonal-antibody-in-healthy-subjects-selectively-inhibits-recruitment-of-ccr6-cells-in-an-experimental-suction-blister
#9
Gerben Bouma, Stefano Zamuner, Kirsty Hicks, Andrew Want, João Oliveira, Arpita Choudhury, Sara Brett, Darren Robertson, Leigh Felton, Virginia Norris, Disala Fernando, Michael Herdman, Ruth Tarzi
AIMS: GSK3050002, a humanized IgG1κ antibody with high binding affinity to human CCL20, was administered in a first-in-human study to evaluate safety, pharmacokinetics (PK) and pharmacodynamics (PD). An experimental skin suction blister model was employed to assess target engagement and the ability of the compound to inhibit recruitment of inflammatory CCR6 expressing cells. METHODS: This study was a randomized, double-blind (sponsor open), placebo-controlled, single-centre, single ascending intravenous dose escalation trial in 48 healthy male volunteers...
March 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28295190/phase-i-study-of-cord-blood-derived-natural-killer-cells-combined-with-autologous-stem-cell-transplantation-in-multiple-myeloma
#10
Nina Shah, Li Li, Jessica McCarty, Indreshpal Kaur, Eric Yvon, Hila Shaim, Muharrem Muftuoglu, Enli Liu, Robert Z Orlowski, Laurence Cooper, Dean Lee, Simrit Parmar, Kai Cao, Catherine Sobieiski, Rima Saliba, Chitra Hosing, Sairah Ahmed, Yago Nieto, Qaiser Bashir, Krina Patel, Catherine Bollard, Muzaffar Qazilbash, Richard Champlin, Katy Rezvani, Elizabeth J Shpall
Multiple myeloma (MM) is a disease with known immune dysregulation. Natural killer (NK) cells have shown preclinical activity in MM. We conducted a first-in-human study of umbilical cord blood-derived (CB) NK cells for MM patients undergoing high dose chemotherapy and autologous haematopoietic stem cell transplantation (auto-HCT). Patients received lenalidomide (10 mg) on days -8 to -2, melphalan 200 mg/m(2) on day -7, CB-NK cells on day -5 and auto-HCT on day 0. Twelve patients were enrolled, three on each of four CB-NK cell dose levels: 5 × 10(6) , 1 × 10(7) , 5 × 10(7) and 1 × 10(8) CB-NK cells/kg...
March 14, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28294526/phase-1-dose-escalating-study-of-the-safety-pharmacokinetics-and-pharmacodynamics-of-activated-factor-x-i-16l
#11
Dana Parsons-Rich, Fei Hua, Gang Li, Constantino Kantaridis, Debra D Pittman, Steven Arkin
BACKGROUND: FXa(I16L) (PF-05230907) is a zymogen-like variant of activated coagulation factor X (FXa). It exhibits enhanced resistance to inactivation by endogenous inhibitors compared with wild-type FXa and restores hemostatic activity in nonclinical models of various bleeding conditions. OBJECTIVES: To evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FXa(I16L) , a phase 1, first-in-human, dose escalation clinical trial in healthy adult volunteers was conducted METHODS: Participants were assigned to 1 of 6 ascending single-dose cohorts (0...
March 14, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28293794/do-all-patients-in-the-phase-i-oncology-trials-need-to-be-hospitalized-domestic-but-outstanding-issues-for-globalization-of-drug-development-in-japan
#12
Akihiko Shimomura, Shunsuke Kondo, Noriko Kobayashi, Satoru Iwasa, Shigehisa Kitano, Kenji Tamura, Yutaka Fujiwara, Noboru Yamamoto
INTRODUCTION: Most trials investigating new drugs around the world, including phase I trials, are conducted in outpatient clinics. However, in Japan, regulatory authority requirements and traditional domestic guidelines often require hospitalization of phase I study participants. PATIENTS AND METHODS: Patients participating in single-agent phase I clinical trials at National Cancer Center Hospital between December 1996 and August 2014 were monitored. Toxicity requiring hospitalization is defined as toxicity that needs intensive treatment...
March 14, 2017: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28291776/first-in-human-phase-1-of-ys110-a-monoclonal-antibody-directed-against-cd26-in-advanced-cd26-expressing-cancers
#13
Eric Angevin, Nicolas Isambert, Véronique Trillet-Lenoir, Benoit You, Jérôme Alexandre, Gérard Zalcman, Philippe Vielh, Françoise Farace, Fanny Valleix, Thomas Podoll, Yu Kuramochi, Itaru Miyashita, Osamu Hosono, Nam H Dang, Kei Ohnuma, Taketo Yamada, Yutaro Kaneko, Chikao Morimoto
BACKGROUND: YS110 is a humanised IgG1 monoclonal antibody with high affinity to the CD26 antigen. YS110 demonstrated preclinical anti-tumour effects without significant side effects. METHODS: This FIH study was designed to determine the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) to assess the tolerance, pharmacokinetics (PK) and pharmacodynamics profiles of YS110 and preliminary efficacy. YS110 were initially administered intravenously once every 2 weeks (Q2W) for three doses and then, based on PK data, once every week (Q1W) for five doses in patients with CD26-expressing solid tumours...
March 14, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28291391/ultrasound-molecular-imaging-with-br55-in-patients-with-breast-and-ovarian-lesions-first-in-human-results
#14
Jürgen K Willmann, Lorenzo Bonomo, Antonia Carla Testa, Pierluigi Rinaldi, Guido Rindi, Keerthi S Valluru, Gianluigi Petrone, Maurizio Martini, Amelie M Lutz, Sanjiv S Gambhir
Purpose We performed a first-in-human clinical trial on ultrasound molecular imaging (USMI) in patients with breast and ovarian lesions using a clinical-grade contrast agent (kinase insert domain receptor [KDR] -targeted contrast microbubble [MBKDR]) that is targeted at the KDR, one of the key regulators of neoangiogenesis in cancer. The aim of this study was to assess whether USMI using MBKDR is safe and allows assessment of KDR expression using immunohistochemistry (IHC) as the gold standard. Methods Twenty-four women (age 48 to 79 years) with focal ovarian lesions and 21 women (age 34 to 66 years) with focal breast lesions were injected intravenously with MBKDR (0...
March 14, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28289709/imaging-mass-spectrometry-demonstrates-age-related-decline-in-human-adipose-plasticity
#15
Christelle Guillermier, Pouneh K Fazeli, Soomin Kim, Mingyue Lun, Jonah P Zuflacht, Jessica Milian, Hang Lee, Hugues Francois-Saint-Cyr, Francois Horreard, David Larson, Evan D Rosen, Richard T Lee, Claude P Lechene, Matthew L Steinhauser
Quantification of stable isotope tracers has revealed the dynamic state of living tissues. A new form of imaging mass spectrometry quantifies isotope ratios in domains much smaller than a cubic micron, enabling measurement of cell turnover and metabolism with stable isotope tracers at the single-cell level with a methodology we refer to as multi-isotope imaging mass spectrometry. In a first-in-human study, we utilize stable isotope tracers of DNA synthesis and de novo lipogenesis to prospectively measure cell birth and adipocyte lipid turnover...
March 9, 2017: JCI Insight
https://www.readbyqxmd.com/read/28282611/phase-ib-dose-finding-study-of-abiraterone-acetate-plus-buparlisib-bkm120-or-dactolisib-bez235-in-patients-with-castration-resistant-prostate-cancer
#16
Christophe Massard, Kim Nguyen Chi, Daniel Castellano, Johann de Bono, Gwenaelle Gravis, Luc Dirix, Jean-Pascal Machiels, Alain Mita, Begona Mellado Gonzalez, Sabine Turri, Joan Maier, Denes Csonka, Arunava Chakravartty, Karim Fizazi
BACKGROUND: The phosphatidylinositol-3-kinase (PI3K)/protein kinase B (Akt) signalling axis and androgen receptor (AR) pathways exhibit reciprocal feedback regulation in phosphatase and tensin homologue (PTEN)-deficient metastatic castration-resistant prostate cancer (CRPC) in preclinical models. This phase Ib study evaluated the pan-PI3K inhibitor buparlisib (BKM120) and the dual pan-PI3K/ mammalian target of rapamycin (mTOR) inhibitor dactolisib (BEZ235) in combination with abiraterone acetate (AA) in patients with CRPC...
March 3, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28280965/radiosynthesis-and-first-in-human-pet-mri-evaluation-with-clinical-grade-18-f-ftc-146
#17
Bin Shen, Jun Hyung Park, Trine Hjørnevik, Peter W Cipriano, Daehyun Yoon, Praveen K Gulaka, Dawn Holly, Deepak Behera, Bonnie A Avery, Sanjiv S Gambhir, Christopher R McCurdy, Sandip Biswal, Frederick T Chin
PURPOSE: Sigma-1 receptors (S1Rs) play an important role in many neurological disorders. Simultaneous positron emission tomography (PET)/magnetic resonance imaging (MRI) with S1R radioligands may provide valuable information for diagnosing and guiding treatment for these diseases. Our previously reported S1R radioligand, [(18)F]FTC-146, demonstrated high affinity for the S1R (K i = 0.0025 nM) and excellent selectivity for the S1R over the sigma-2 receptor (S2Rs; K i = 364 nM) across several species (from mouse to non-human primate)...
March 9, 2017: Molecular Imaging and Biology: MIB: the Official Publication of the Academy of Molecular Imaging
https://www.readbyqxmd.com/read/28280089/successful-transfer-of-umbilical-cord-blood-cd34-hematopoietic-stem-and-progenitor-derived-nk-cells-in-older-acute-myeloid-leukemia-patients
#18
Harry Dolstra, Mieke W H Roeven, Jan Spanholtz, Basav N Hangalapura, Marleen Tordoir, Frans Maas, Marij Leenders, Fenna Bohme, Nina Kok, Carel Trilsbeek, Jos Paardekooper, Anniek B van der Waart, Peter E Westerweel, Tjeerd J F Snijders, Jan J Cornelissen, Gerard M J Bos, Hans F M Pruijt, Aniek O De Graaf, Bert van der Reijden, Joop H Jansen, Arnold van der Meer, Gerwin Huls, Jeannette Cany, Frank Preijers, Nicole M A Blijlevens, Nicolaas M Schaap
PURPOSE: Older acute myeloid leukemia (AML) patients have a poor prognosis, therefore novel therapies are needed. Allogeneic natural killer (NK) cells have been adoptively transferred with promising clinical results. Here, we report the first-in-human study exploiting an unique scalable NK cell product generated ex vivo from CD34+ hematopoietic stem and progenitor cells (HSPCs) from partially HLA-matched umbilical cord blood units. EXPERIMENTAL DESIGN: Ten older AML patients in morphologic complete remission received an escalating HSPC-NK cell dose (between 3 and 30x10^6/kg body weight) after lymphodepleting chemotherapy without cytokine boosting...
March 9, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28273130/volunteer-feedback-and-perceptions-after-participation-in-a-phase-i-first-in-human-ebola-vaccine-trial-an-anonymous-survey
#19
Julie-Anne Dayer, Claire-Anne Siegrist, Angela Huttner
The continued participation of volunteers in clinical trials is crucial to advances in healthcare. Few data are available regarding the satisfaction and impressions of healthy volunteers after participation in phase I trials, many of which lead to unexpected adverse events. We report feedback from over 100 adult volunteers who took part in a first-in-human trial conducted in a high-income country testing an experimental Ebola vaccine causing significant reactogenicity, as well as unexpected arthritis in one fifth of participants...
2017: PloS One
https://www.readbyqxmd.com/read/28265009/preclinical-mammalian-safety-studies-of-epharna-dopc-nanoliposomal-epha2-targeted-sirna
#20
Michael J Wagner, Rahul Mitra, Mark J McArthur, Wallace Baze, Kirstin Barnhart, Sherry Wu, Cristian Rodriguez-Aguayo, Xinna Zhang, Robert L Coleman, Gabriel Lopez-Berestein, Anil K Sood
To address the need for efficient and biocompatible delivery systems for systemic siRNA delivery, we developed 1,2-Dioleoyl-sn-Glycero-3-Phosphatidylcholine (DOPC) nanoliposomal EphA2-targeted therapeutic (EPHARNA). Here, we performed safety studies of EPHARNA in murine and primate models. Single dosing of EPHARNA was tested at 5 concentrations in mice (N=15 per group) and groups were sacrificed on days 1, 14, and 28 for evaluation of clinical pathology and organ toxicity. Multiple dosing of EPHARNA was tested in mice and Rhesus macaques twice weekly at two dose levels in each model...
March 6, 2017: Molecular Cancer Therapeutics
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