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Pharmacology & Pharmacy
Yimin Yu, Jingjing He, Zhiwei Huang, Yan Li, Ying Wu, Yifeng Shen, Yanling Zhou, Cungang Bao, Zhiping Jin, Huafang Li
Summary: This study evaluated the pharmacokinetic profiles and safety of JX11502MA in healthy volunteers, and found that it was well tolerated at doses ranging from 0.25 to 3 mg, suggesting it has the potential to be a favorable treatment option for schizophrenia patients.
EXPERT OPINION ON INVESTIGATIONAL DRUGS
(2023)
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Pharmacology & Pharmacy
Min Wu, Jixuan Sun, Dandan Wu, Jia Xu, Jin Wei, Zhaohe Wang, Jinchen Yu, Shengfeng Li, Hong Zhang, Yanhua Ding
Summary: The study confirmed the PK similarity between BAT2506 and golimumab, showing good tolerance of BAT2506 in healthy subjects with no differences in safety and immunogenicity between the two drugs.
EXPERT OPINION ON INVESTIGATIONAL DRUGS
(2021)
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Pharmacology & Pharmacy
Kai Huang, Ying Ding, Linling Que, Nannan Chu, Yunfei Shi, Zhenzhong Qian, Wei Qin, Yuanxin Chen, Xianghong Gu, Jiakun Wang, Zhiwei Zhang, Jianguo Xu, Qing He
Summary: This study aimed to investigate the safety, tolerability, and pharmacokinetics of WXFL10203614 in healthy Chinese subjects. A total of 592 subjects were enrolled, and results showed good safety and tolerability of WXFL10203614 in all dose levels, with dose-related changes in pharmacokinetic parameters. The findings support further clinical development of WXFL10203614 in patients with rheumatoid arthritis.
FRONTIERS IN PHARMACOLOGY
(2022)
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Infectious Diseases
Yingying Hu, Qiong Wei, Xingchen Bian, Xinyi Yang, Jicheng Yu, Jingjing Wang, Haijing Yang, Guoying Cao, Xiaojie Wu, Jing Zhang
Summary: This study investigated the pharmacokinetics and safety of oral and intravenous lefamulin in healthy Chinese subjects, and evaluated the efficacy of the intravenous administration regimen. The results showed that lefamulin exhibited extensive distribution, and the PK parameters were consistent between oral and intravenous administration. The regimen was found to be microbiologically effective and well-tolerated.
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Medicine, Research & Experimental
Aixin Shi, Panpan Xie, Lasse Lykke Nielsen, Trine Vang Skjoth, Xuemei He, Sine Pfeiffer Haugaard
Summary: This study evaluated the pharmacokinetics, safety, and tolerability of once-weekly subcutaneous semaglutide in healthy Chinese subjects. Results showed that semaglutide exposure increased dose-proportionally in healthy Chinese subjects, and treatment with once-weekly subcutaneous semaglutide was well tolerated. The findings suggest that no dose adjustment is needed for semaglutide in Chinese patients with T2D.
ADVANCES IN THERAPY
(2021)
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Pharmacology & Pharmacy
Hanjing Chen, Weili Chen, Fei Yuan, Qingcheng Guo, Xunmin Zhang, Chenguang Wang, Xuening Li
Summary: This study evaluated the bioequivalence of CMAB807, a biosimilar to denosumab, for the treatment of osteoporosis. The results showed that CMAB807 had similar pharmacokinetics, pharmacodynamics, safety, and immunogenicity to denosumab. CMAB807 could potentially be a new treatment option for patients with osteoporosis.
FRONTIERS IN PHARMACOLOGY
(2022)
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Microbiology
Haijing Yang, Yi Jin, Hailin Wang, Hong Yuan, Jingjing Wang, Size Li, Yingying Hu, Huahui Yang, Xin Li, Hong Liang, Jufang Wu, Guoying Cao, Jing Zhang
Summary: Contezolid acefosamil showed good safety and pharmacokinetic profiles in healthy Chinese subjects, supporting further clinical development.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2023)
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Pharmacology & Pharmacy
Guoying Cao, Jingjing Wang, Jinjie He, Yingying Hu, Haijing Yang, Linling Que, Xianghong Gu, Jicheng Yu, Xiaojie Wu, Jufang Wu, Wei Fang, Qing He, Jing Zhang
Summary: This study aimed to investigate the pharmacokinetics, safety, and immunogenicity of LZM008 and evaluate its similarity to wtocilizumab in Chinese healthy male subjects. The results showed that LZM008 exhibited similar pharmacokinetic characteristics and safety profiles to the reference product, ACTEMRA (R).
FRONTIERS IN PHARMACOLOGY
(2023)
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Chemistry, Medicinal
Jin Wang, Huan Zhang, Rui Wang, Yun Cai
Summary: In this study, the pharmacokinetics, bioequivalence and safety profiles of 90 mg ticagrelor tablets and their active metabolite were evaluated in healthy Chinese subjects under fasting and fed conditions. The results showed no significant differences in PK parameters and bioequivalence between the test and reference drugs, with no severe adverse events observed.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
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Pharmacology & Pharmacy
Yanli Wang, Qiaohuan Deng, Zhenyue Gao, Guangwen Liu, Zhengjie Su, Yicheng Zhao, Lixiu Zhang, Haimiao Yang
Summary: This study investigated the pharmacokinetics, bioequivalence, and safety of generic sunitinib and its original product Sutent (R) in healthy Chinese subjects through a phase-I clinical trial. The results demonstrated that the two drugs had comparable pharmacokinetics and were bioequivalent. Both drugs also exhibited good safety profiles.
FRONTIERS IN PHARMACOLOGY
(2023)
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Pharmacology & Pharmacy
Xiaojiao Li, Lei Gao, Jingrui Liu, Hong Zhang, Hong Chen, Lizi Yang, Min Wu, Cuiyun Li, Xiaoxue Zhu, Yanhua Ding, Li Sun
Summary: HEC30654, a selective 5-HT6 receptor antagonist, was found to be safe and well-tolerated in healthy Chinese subjects at single doses up to 30 mg, with potential therapeutic benefits for cognitive disorders based on preclinical efficacy.
FRONTIERS IN PHARMACOLOGY
(2021)
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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)
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Chemistry, Medicinal
Xuemei He, Xin Gao, Panpan Xie, Yuan Liu, Wenjing Bai, Yue Liu, Aixin Shi
Summary: This study assessed the pharmacokinetic and pharmacodynamic profiles, safety, and tolerability of sotagliflozin in Chinese healthy subjects. The results showed that sotagliflozin was rapidly absorbed with dose-proportional systemic exposure and a moderate degree of accumulation. Both 200mg and 400mg doses of sotagliflozin per day were well tolerated in Chinese healthy subjects.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2022)
Article
Pharmacology & Pharmacy
Shanshan Li, Xiaojie Wu, Nanyang Li, Guoying Cao, Jingjing Wang, Yuancheng Chen, Size Li, Jinjie He, Jufang Wu, Haijing Yang, Ke Lin, Chao Qiu, Angela Liu, He Zhou, Francisco Adrian, Liang Schweizer, Wenhong Zhang, Jingwen Gu, Jing Zhang
Summary: The aim of this study was to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HFB30132A in healthy Chinese adults. Results showed that HFB30132A was safe and generally well-tolerated after single IV doses of 1,000 mg or 2,000 mg, and did not induce an immunogenic response. The findings support further clinical development of HFB30132A.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Microbiology
Mary Beth Wire, Soo Youn Jun, In-Jin Jang, Seung-Hwan Lee, Jun Gi Hwang, David B. Huang
Summary: This study randomized 32 healthy male subjects into different cohorts to evaluate the safety and tolerability of the antistaphylococcal lysin LSVT-1701. Exposure to LSVT-1701 increased in a dose-proportional manner and did not accumulate. The treatment-emergent adverse events were mostly mild, with the most common being chills and fever.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2022)