Article
Clinical Neurology
Beibei Liang, Jin Wang, Guanxuanzi Zhang, Rui Wang, Yun Cai
Summary: This study aimed to assess the safety, tolerability, and pharmacokinetics of SYHA1402 in healthy Chinese subjects. The results showed that SYHA1402 was well tolerated and safe when administered as a single dose in the range of 25-800 mg, and over 50% of the unchanged drug was excreted in urine.
NEUROLOGY AND THERAPY
(2023)
Article
Microbiology
Xiaojiao Li, Yusi Liu, Hanxin Yao, Meng Wang, Lei Gao, Jinfeng Lou, John Mao, Wenqiang Wu, Yixin Zhou, Yanan Tang, Wenhao Yan, Yanbin Hu, Charles Ding, Shuhui Chen, Junqi Niu, Yanhua Ding
Summary: GST-HG131 has shown potential as a therapeutic option for CHB infection, as it reduces levels of HBsAg in animals. The phase I trial in healthy Chinese subjects demonstrated the safety and tolerability of GST-HG131 at various doses, with the potential to meet therapeutic requirements.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2022)
Article
Immunology
Adrie Bekker, Eric H. Decloedt, Gretchen Slade, Mark F. Cotton, Helena Rabie, Tim R. Cressey
Summary: Abacavir could be a potential option for HIV prophylaxis and early treatment in neonates, with higher exposures reported in neonates who received a single dose before 15 days of life, without any adverse events reported.
CLINICAL INFECTIOUS DISEASES
(2021)
Article
Medicine, Research & Experimental
Hanjing Chen, Weili Chen, Hui Li, Hongrong Xu, Fei Yuan, Lei Sheng, Chao Liu, Pingping Lin, Mengjie Yang, Xuening Li, Yang Liu, Brittany Marie Walker, Ferdous Gheyas, Marian Iwamoto, S. Aubrey Stoch, Rajesh Krishna
Summary: Anacetrapib, a novel CETP inhibitor, shows comparable pharmacokinetic properties in Chinese subjects as observed in black and white populations. Single and once-daily administration of anacetrapib was well tolerated in healthy Chinese subjects in this study.
ADVANCES IN THERAPY
(2021)
Article
Endocrinology & Metabolism
Ki Young Huh, Jun Gi Hwang, Wonjung Shin, Seungjae Baek, JaeDuk Choi, Nora Lee, Young Min Cho, Howard Lee
Summary: HM15136, a novel long-acting glucagon analogue, was shown to be safe and well tolerated in doses ranging from 10-120 μg/kg in a randomized, double-blind, placebo-controlled study. It increased blood glucose levels and suppressed the secretion of endogenous glucagon.
DIABETES OBESITY & METABOLISM
(2022)
Article
Chemistry, Medicinal
Ling Yang, Qi Shen, Chao Hu, Ying Wang, Xiaohong Zhu, Shiqing Shu, Zhu Luo
Summary: The study indicated that Imrecoxib exhibited good pharmacokinetic and safety profiles in elderly healthy subjects, suggesting no dose adjustment is required for this population.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2022)
Article
Microbiology
Jon Bruss, Troy Lister, Vipul K. Gupta, Emily Stone, Lisa Morelli, Yang Lei, David Melnick
Summary: SPR206, a novel polymyxin derivative, shows potent activity against multidrug-resistant bacteria and demonstrates good safety and tolerability in healthy subjects. Drug exposure and excretion are dose-dependent, with minimal accumulation and no evidence of nephrotoxicity observed.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Chemistry, Medicinal
Benjamin R. Taft, Fumiaki Yokokawa, Tom Kirrane, Anne-Catherine Mata, Richard Huang, Nicole Blaquiere, Grace Waldron, Bin Zou, Oliver Simon, Subramanyam Vankadara, Wai Ling Chan, Mei Ding, Sandra Sim, Judith Straimer, Armand Guiguemde, Suresh B. Lakshminarayana, Jay Prakash Jain, Christophe Bodenreider, Christopher Thompson, Christian Lanshoeft, Wei Shu, Eric Fang, Jafri Qumber, Katherine Chan, Luying Pei, Yen-Liang Chen, Hanna Schulz, Jessie Lim, Siti Nurdiana Abas, Xiaoman Ang, Yugang Liu, Inigo Angulo-Barturen, Maria Belen Jimenez-Diaz, Francisco Javier Gamo, Benigno Crespo-Fernandez, Philip J. Rosenthal, Roland A. Cooper, Patrick Tumwebaze, Anna Caroline Campos Aguiar, Brice Campo, Simon Campbell, Jurgen Wagner, Thierry T. Diagana, Christopher Sarko
Summary: A highly potent antimalarial compound, INE963 (1), with favorable pharmacological properties, has been identified through high-throughput screening and shows potential for curing uncomplicated malaria.
JOURNAL OF MEDICINAL CHEMISTRY
(2022)
Article
Chemistry, Medicinal
Guolan Wu, Huili Zhou, Duo Lv, Ruling Zheng, Lihua Wu, Songxia Yu, Jiejing Kai, Nana Xu, Lie Gu, Nanfang Hong, Jianzhong Shentu
Summary: The purpose of this study was to investigate the safety, tolerability, and pharmacokinetics of suramin in healthy Chinese volunteers. The results showed that suramin's maximum plasma concentration and area under the plasma concentration-time curve increased in a dose-proportional manner. Suramin can be detected in urine samples for longer periods. The study suggested that 10 mg/kg or 15 mg/kg could be an appropriate dose for future multiple-dose studies.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2023)
Article
Pharmacology & Pharmacy
Jun Gi Hwang, SeungHwan Lee, Wan Huh, Jumi Han, Jaeseong Oh, In-Jin Jang, Kyung-Sang Yu
Summary: The study evaluated the pharmacokinetics, pharmacodynamics, and safety of DWP16001 in healthy subjects after single and multiple doses, showing dose-dependent increase in urinary glucose excretion after multiple doses and good tolerability of DWP16001 across all dose groups.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Sufeng Zhou, Lijun Xie, Chen Zhou, Yuqing Zhao, Lu Wang, Sijia Ding, Juan Chen, Bei Zhu, Mei Su, Feng Shao
Summary: This study evaluated the safety, pharmacokinetics, pharmacodynamics, and food effect of Keverprazan in healthy Chinese subjects. The results showed that Keverprazan is well-tolerated and provides significant stable and lasting inhibition efficacy of intragastric acidity at a dose of 20mg.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Article
Rheumatology
Tomonori Ishii, Yukio Sato, Yasuhiko Munakata, Miyuki Kajiwara, Yoshinori Takahashi, Hubert van Hoogstraten, Christine Xu, Naoto Kato, Toshiya Takahashi
Summary: This study assessed the safety and pharmacokinetics of single-dose subcutaneous sarilumab or tocilizumab with or without methotrexate in Japanese rheumatoid arthritis patients, as well as the pharmacodynamics of the drugs. The results showed that the pharmacokinetics, pharmacodynamics, and safety profiles of single-dose sarilumab with or without methotrexate were as expected in Japanese patients with RA.
MODERN RHEUMATOLOGY
(2023)
Article
Pharmacology & Pharmacy
Yue Hu, Hong Zhang, Xiaojiao Li, Jiajia Mai, Lizhi Yang, Jie Yan, Ying Li, Jingchao Sun, Wenjie Xu, Shiying He, Jinfeng Li, Min Wu
Summary: The study evaluated the safety, pharmacokinetic, and pharmacodynamic profiles of S086 in healthy Chinese volunteers, showing no significant safety concerns and supporting the use of S086 in patients with heart failure in a Phase II study.
EXPERT OPINION ON INVESTIGATIONAL DRUGS
(2022)
Article
Plant Sciences
Ruihua Dong, Lijun Li, Hongzhi Gao, Kun Lou, Hongmei Luo, Sheng Hao, Jing Yuan, Zeyuan Liu
Summary: Scutellaria baicalensis (Huang-Qin in Chinese) is an herb high in flavonoids, with baicalein being the most abundant flavonoid. This study evaluated the safety and pharmacokinetic characteristics of baicalein in vivo, showing that baicalein tablets within the studied dose range were safe and well-tolerated in healthy Chinese subjects. Further research is needed to assess safety and efficacy in target patients.
JOURNAL OF ETHNOPHARMACOLOGY
(2021)
Article
Microbiology
John S. Bradley, Jennifer L. Goldman, Laura P. James, Byron Kaelin, Breanne H. Y. Gibson, Antonio Arrieta
Summary: This study aimed to evaluate the safety and pharmacokinetics of telavancin in pediatric patients. The results showed that telavancin was well-tolerated in all age groups, with increased clearance and reduced exposure compared to adults.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2023)