Novel and emerging therapies for B cell lymphoma

by Sabarish Ayyappan, Kami Maddocks
Published 2019-07-01

A first-in-human study investigating biodistribution, safety and recommended dose of a new radiolabeled MAb targeting FZD10 in metastatic synovial sarcoma patients

by Anne-Laure Giraudet, Philippe Alexandre Cassier, Chicaco Iwao-Fukukawa, Gwenaelle Garin, Jean-Noël Badel, David Kryza, Sylvie Chabaud, Laurence Gilles-Afchain, Gilles Clapisson, Claude Desuzinges, David Sarrut, Adrien Halty, Antoine Italiano, Masaharu Mori, Takuya Tsunoda, Toyomasa Katagiri, Yusuke Nakamura, Laurent Alberti, Claire Cropet, Simon Baconnier, Sandrine Berge-Montamat, David Pérol, Jean-Yves Blay
Published 2018-06-01

A first-in-human study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of KM-819 (FAS-associated factor 1 inhibitor), a drug for Parkinson’s d...

by Shin W, Lim KS, Kim MK, Kim HS, Hong J, Jhee S, Kim J, Yoo S, Chung YT, Lee JM, Cho DY
Published 2019-03-01

Peptide Vaccination Against PD-L1 With IO103 a Novel Immune Modulatory Vaccine in Multiple Myeloma: A Phase I First-in-Human Trial

by Nicolai Grønne Jørgensen, Nicolai Grønne Jørgensen, Uffe Klausen, Uffe Klausen, Jacob Handlos Grauslund, Carsten Helleberg, Thomas Granum Aagaard, Trung Hieu Do, Shamaila Munir Ahmad, Lars Rønn Olsen, Tobias Wirenfeldt Klausen, Marie Fredslund Breinholt, Morten Hansen, Evelina Martinenaite, Özcan Met, Özcan Met, Inge Marie Svane, Lene Meldgaard Knudsen, Mads Hald Andersen, Mads Hald Andersen
Published 2020-11-01

Taking Optogenetics into the Human Brain: Opportunities and Challenges in Clinical Trial Design

by White M, Mackay M, Whittaker RG
Published 2020-08-01

Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase

by Lázara Martínez Muñoz
Published 2018-01-01

Pharmacokinetics and tolerability of MB12066, a beta-lapachone derivative targeting NAD(P)H:quinone oxidoreductase 1: two independent, double-blind, placebo-controlled, combined si...

by Kim S, Lee S, Cho JY, Yoon SH, Jang IJ, Yu KS
Published 2017-11-01

Reviewing the role of healthy volunteer studies in drug development

by Joyson J. Karakunnel, Nam Bui, Latha Palaniappan, Keith T. Schmidt, Kenneth W. Mahaffey, Briggs Morrison, William D. Figg, Shivaani Kummar
Published 2018-12-01

Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013

by Suh HY, Peck CC, Yu KS, Lee H
Published 2016-12-01

A Single Animal Species-Based Prediction of Human Clearance and First-in-Human Dose of Monoclonal Antibodies: Beyond Monkey

by Iftekhar Mahmood
Published 2021-09-01

A few ethical issues in translational research for gene and cell therapy

by Luciana Riva, Carlo Petrini
Published 2019-11-01

Single- and multiple-dose tolerability, safety, pharmacokinetics, and pharmacodynamics of the dual endothelin receptor antagonist aprocitentan in healthy adult and elderly subjects

by Sidharta PN, Melchior M, Kankam MK, Dingemanse J
Published 2019-03-01

A Phase 1 first‐in‐human study of the safety, tolerability, and pharmacokinetics of the ROBO2 fusion protein PF‐06730512 in healthy participants

by Chay Ngee Lim, Constantino Kantaridis, Isabelle Huyghe, Donal Gorman, Stephen Berasi, Gabriele E. Sonnenberg
Published 2021-08-01

Pharmacokinetics and tolerability of DA-8031, a novel selective serotonin reuptake inhibitor for premature ejaculation in healthy male subjects

by Shin D, Lee S, Yi S, Yoon SH, Cho JY, Bahng MY, Jang IJ, Yu KS
Published 2017-03-01

Cell-based interventions in utero: time to reconsider

by Nancy M. P. King, Nancy M. P. King, Ana S. Iltis, Ana S. Iltis
Published 2014-09-01

Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study

by Katsuhisa Yamada, Maeda Kenichiro, Yoichi M. Ito, Fujio Inage, Toshiyuki Isoe, Nozomi Yokota, Osamu Sugita, Norihiro Sato, Khin Khin Tha, Norimasa Iwasaki, Teruyo Arato, Hideki Sudo
Published 2021-09-01

Safety and nonclinical and clinical pharmacokinetics of PC945, a novel inhaled triazole antifungal agent

by Lindsey Cass, Alison Murray, Amanda Davis, Kathy Woodward, Muna Albayaty, Kazuhiro Ito, Pete Strong, John Ayrton, Charlie Brindley, Jayne Prosser, John Murray, Eddie French, Phillip Haywood, Christopher Wallis, Garth Rapeport
Published 2021-02-01

Emerging therapies for relapsed/refractory multiple myeloma: CAR-T and beyond

by Christopher T. Su, J. Christine Ye
Published 2021-07-01

A phase 1 study of dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor in Chinese patients with advanced breast cancer

by Pin Zhang, Binghe Xu, Lin Gui, Wenna Wang, Meng Xiu, Xiao Zhang, Guilan Sun, Xiaoyu Zhu, Jianjun Zou
Published 2021-04-01

Targeted therapy in advanced non-small cell lung cancer: current advances and future trends

by Umair Majeed, Rami Manochakian, Yujie Zhao, Yanyan Lou
Published 2021-07-01