Development of an oral regimen of unithiol for the treatment of snakebite envenoming: a phase 1 open-label dose-escalation safety trial and pharmacokinetic analysis in healthy Keny... by Michael Abouyannis, Yvonne K. Nyambura, Samson Ngome, Debra Riako, Jennifer Musyoki, Charles Muiruri, Benedict Orindi, Laura Else, Alieu Amara, Laura Dickinson, Rachel H. Clare, Laura-Oana Albulescu, Adam P. Westhorpe, Jeroen Kool, Ifedayo Adetifa, Francis M. Ndungu, Richard FitzGerald, Saye Khoo, David G. Lalloo, Nicholas R. Casewell, Mainga Hamaluba

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GUIP1: a R package for dose escalation strategies in phase I cancer clinical trials by D. Dinart, J. Fraisse, D. Tosi, A. Mauguen, C. Touraine, S. Gourgou, M. C. Le Deley, C. Bellera, C. Mollevi

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Latozinemab, a novel progranulin-elevating therapy for frontotemporal dementia by Michael Kurnellas, Ananya Mitra, Tina Schwabe, Robert Paul, Andrew E. Arrant, Erik D. Roberson, Michael Ward, Felix Yeh, Hua Long, Arnon Rosenthal

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Preclinical and first-in-human evaluation of AL002, a novel TREM2 agonistic antibody for Alzheimer’s disease by Hua Long, Adam Simmons, Arthur Mayorga, Brady Burgess, Tuan Nguyen, Balasubrahmanyam Budda, Anna Rychkova, Herve Rhinn, Ilaria Tassi, Michael Ward, Felix Yeh, Tina Schwabe, Robert Paul, Sara Kenkare-Mitra, Arnon Rosenthal

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Safety, Tolerability, and Pharmacokinetics of Adrenomedullin in Healthy Males: A Randomized, Double-Blind, Phase 1 Clinical Trial by Kita T, Kaji Y, Kitamura K

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Optimal biological dose: a systematic review in cancer phase I clinical trials by J. Fraisse, D. Dinart, D. Tosi, C. Bellera, C. Mollevi

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Safety and immunogenicity of an Escherichia coli-produced bivalent human papillomavirus type 6/11 vaccine: A dose-escalation, randomized, double-blind, placebo-controlled phase 1 t... by Zhao-Jun Mo, Zhao-Feng Bi, Wei Sheng, Qi Chen, Teng Huang, Ming-Qiang Li, Xue-Lian Cui, Ya-Hui Wangjiang, Bi-Zhen Lin, Feng-Zhu Zheng, Guang Sun, Ya-Fei Li, Ya Zheng, Si-Jie Zhuang, Ying-Ying Su, Hui-Rong Pan, Shou-Jie Huang, Ting Wu, Jun Zhang, Ning-Shao Xia

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FIGHT‐102: A phase 1 study of pemigatinib in Japanese patients with advanced malignancies by Yutaka Fujiwara, Yasutoshi Kuboki, Masayuki Furukawa, Nobumasa Mizuno, Hiroki Hara, Tatsuya Ioka, Makoto Ueno, Yasuo Takahashi, Shunji Takahashi, Shinji Takeuchi, Christine Lihou, Tao Ji, Chenwei Tian, Toshio Shimizu

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Engineered bacteria to accelerate wound healing: an adaptive, randomised, double-blind, placebo-controlled, first-in-human phase 1 trialResearch in context by Emelie Öhnstedt, Evelina Vågesjö, Andreas Fasth, Hava Lofton Tomenius, Pia Dahg, Sofia Jönsson, Nisha Tyagi, Mikael Åström, Zhanar Myktybekova, Lovisa Ringstad, Margareth Jorvid, Peter Frank, Per Hedén, Stefan Roos, Mia Phillipson

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A Pilot Study Evaluating the Safety of Intravenously Administered Human Amnion Epithelial Cells for the Treatment of Hepatic Fibrosis by Rebecca Lim, Rebecca Lim, Alexander Hodge, Alexander Hodge, Gregory Moore, Gregory Moore, Euan M. Wallace, Euan M. Wallace, William Sievert, William Sievert

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Safety, Tolerability, and Pharmacokinetics of NIM‐1324 an Oral LANCL2 Agonist in a Randomized, Double‐Blind, Placebo‐Controlled Phase I Clinical Trial by Andrew Leber, Raquel Hontecillas, Nuria Tubau‐Juni, Josep Bassaganya‐Riera

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Phase 1 Clinical Trial of Elamipretide in Intermediate Age-Related Macular Degeneration and High-Risk Drusen by Michael J. Allingham, MD, PhD, Priyatham S. Mettu, MD, Scott W. Cousins, MD

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The early-onset febrile reaction following vaccination and associated factors: An exploratory sub-study based on the Ebola vaccine clinical trial by Qigang Dai, Qi Liang, Yuemei Hu, Fanyue Meng, Jingxin Li, Lihua Hou, Hailong Zhou, Kai Chu, Xiaokui Hu, Rong Tang, Wenjuan Wang, Jialei Hu, Haodi Huang, Zhen Li, Shuqi Yang, Fengcai Zhu

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Phase 1 Clinical Trial of Elamipretide in Dry Age-Related Macular Degeneration and Noncentral Geographic Atrophy by Priyatham S. Mettu, MD, Michael J. Allingham, MD, PhD, Scott W. Cousins, MD

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A phase I study of weekly doxorubicin and oral topotecan for patients with relapsed or refractory small cell lung cancer (SCLC): A Fred and Pamela Buffet Cancer Center Clinical Tri... by Vinicius Ernani, Rahat Jahan, Lynette M. Smith, Alissa S. Marr, Sarah E. Kimbrough, Mary E. Kos, Jolene Tijerina, Shannon Pivovar, Imayavaramban Lakshmanan, Marsha Ketcham, Sanchita Rauth, Kavita Mallya, Mohd W Nasser, Maneesh Jain, Anne Kessinger, Surinder K. Batra, Apar Kishor Ganti

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Pharmacokinetics and pharmacodynamics across infusion rates of intravenously administered nipocalimab: results of a phase 1, placebo-controlled study by Jocelyn H. Leu, An Vermeulen, Claudia Abbes, Santiago Arroyo, William S. Denney, Leona E. Ling

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A Phase 1 Study of IRX195183, a RARα-Selective CYP26 Resistant Retinoid, in Patients With Relapsed or Refractory AML by Alexander J. Ambinder, Kelly Norsworthy, Daniela Hernandez, Laura Palau, Bogdan Paun, Amy Duffield, Rosh Chandraratna, Martin Sanders, Ravi Varadhan, Richard J. Jones, B. Douglas Smith, Gabriel Ghiaur

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Safety and immunogenicity of an HIV-1 prefusion-stabilized envelope trimer (Trimer 4571) vaccine in healthy adults: A first-in-human open-label, randomized, dose-escalation, phase... by Katherine V. Houser, Martin R. Gaudinski, Myra Happe, Sandeep Narpala, Raffaello Verardi, Edward K. Sarfo, Angela R. Corrigan, Richard Wu, Ro Shauna Rothwell, Laura Novik, Cynthia S. Hendel, Ingelise J. Gordon, Nina M. Berkowitz, Cora Trelles Cartagena, Alicia T. Widge, Emily E. Coates, Larisa Strom, Somia Hickman, Michelle Conan-Cibotti, Sandra Vazquez, Olga Trofymenko, Sarah Plummer, Judy Stein, Christopher L. Case, Martha Nason, Andrea Biju, Danealle K. Parchment, Anita Changela, Cheng Cheng, Hongying Duan, Hui Geng, I-Ting Teng, Tongqing Zhou, Sarah O'Connell, Chris Barry, Kevin Carlton, Jason G. Gall, Britta Flach, Nicole A. Doria-Rose, Barney S. Graham, Richard A. Koup, Adrian B. McDermott, John R. Mascola, Peter D. Kwong, Julie E. Ledgerwood

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Phase 1 study of latozinemab in progranulin‐associated frontotemporal dementia by Michael Ward, Lawrence P. Carter, Julie Y. Huang, Daniel Maslyar, Balasubrahmanyam Budda, Robert Paul, Arnon Rosenthal

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Personality vulnerabilities and adverse event reporting in phase 1 clinical studies by Joanna Skommer, Krish Gunesh, Thomas M. Polasek

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