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
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
Clinical Neurology
Richard Bertz, Rajinder Bhardwaj, Beth A. A. Morris, Eric Ashbrenner, Vladimir Coric, Robert Croop
Summary: This study evaluated the safety, tolerability, and pharmacokinetics of the oral capsule formulation of rimegepant for the treatment and prevention of acute migraine. The results showed that rimegepant was safe and well tolerated, with no significant effects on blood pressure and heart rate.
Article
Microbiology
Paul Bruinenberg, Jerry Nedelman, Tian J. Yang, Fran Pappas, Dan Everitt
Summary: The study aimed to evaluate the safety and tolerability of sutezolid tablets in healthy adult subjects and determine its pharmacokinetics. The results showed that sutezolid was well tolerated in fasting healthy adults when administered in doses ranging from 300mg to 1800mg. The maximum concentration of sutezolid, PNU-101603, and PNU-101244 increased in a less-than-proportional manner with an increase in sutezolid dose, while total exposure increased proportionally with dose.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2022)
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
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
Infectious Diseases
Na Liu, Xiaohong Wang, Jixiang Zhu, Sumit Basu, Yudong Wei, Bei Yan, Hui Wang, Francheska Colon-Gonzalez, Hwa-Ping Feng, Fang Sun, Haiyan Li, Yanqiao Zang
Summary: This study evaluated the pharmacokinetics, safety, and tolerability of C/T in 12 healthy Chinese participants. The results showed that the pharmacokinetics and safety/tolerability of C/T in healthy Chinese participants were comparable to that in other populations, supporting the use of C/T for the treatment of Chinese patients.
INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
(2023)
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
Medicine, General & Internal
Cuiyun Li, Min Wu, Hong Zhang, Xiaoxue Zhu, Li Fu, Shuo Wang, Mingming Lu, Dafang Zhong, Yanhua Ding
Summary: This study evaluated the safety and pharmacokinetic profiles of forsythin in healthy Chinese subjects. The results showed that forsythin is well-absorbed and extensively metabolized after single or multiple doses. The findings support further evaluation of its efficacy in individuals with the common cold or influenza.
ANNALS OF MEDICINE
(2023)
Article
Chemistry, Medicinal
Hongjie Qian, Qian Chen, Liyu Lang, Yang Zou, Huahua Pu, Liang Xin, Rong Song, Tingting Li, Huijuan Zhu, Yu Wang, Guanghui Tian, Jingshan Shen, Hualiang Jiang, Chen Yu, Zhen Wang, Jingying Jia
Summary: The study aimed to evaluate the efficacy of TPN171H for PAH, with results showing linear metabolism and food effect in healthy subjects; minimal impact on blood pressure and color discrimination, good safety and tolerability.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Microbiology
Xiaohong Wang, Na Liu, Yudong Wei, Shuang Zhang, Haiyan Li, Bei Yan, Munjal Patel, Hui Wang, Keith E. Boundy, Francheska Colon-Gonzalez, Yanqiao Zang, Xumin Zhao
Summary: This study evaluated the pharmacokinetics, safety, and tolerability of relebactam/imipenem/cilastatin in 12 healthy Chinese participants. The results showed that the drug behaved similarly in Chinese participants compared to other ethnicities, supporting its use in Chinese patients.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Microbiology
Cuiyun Li, Min Wu, Hong Zhang, Jiajia Mai, Lizhi Yang, Yanhua Ding, Junqi Niu, John Mao, Wenqiang Wu, Dong Zhang, Yanan Tang, Wenhao Yan
Summary: HBV CAMs are promising therapeutic agents for chronic hepatitis B, with GST-HG141 showing good safety and pharmacokinetic profiles in healthy Chinese volunteers. Further evaluation of GST-HG141 efficacy in individuals with chronic hepatitis B is supported by these findings.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Pharmacology & Pharmacy
Shining Wang, Grace Chen, Emilio Merlo Pich, John Affinito, Michael Cwik, Helene Faessel
Summary: Soticlestat is a selective inhibitor of cholesterol 24-hydroxylase, developed for the treatment of rare developmental and epileptic encephalopathies. In a first-in-human study, it was well tolerated and rapidly absorbed when administered as an oral solution.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(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)