The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial
文献类型：期刊论文
| 作者 | Gou,Zhong-Ping; Zhao,Yun-Li; Zou,Lin-Ling; Wang,Ying; Shu,Shi-Qing; Zhu,Xiao-Hong; Zheng,Li; Shen,Qi; Luo,Zhu; Miao,Jia |
| 刊名 | PHARMACEUTICAL BIOLOGY
 |
| 出版日期 | 2021 |
| 卷号 | 59期号:1页码:484-493 |
| 关键词 | Clinical safety healthy subject dose-escalation study MONOTERPENOID INDOLE ALKALOIDS FLIGHT MASS-SPECTROMETRY EXTRACT IDENTIFICATION CONSTITUENTS |
| ISSN号 | 1388-0209 |
| DOI | 10.1080/13880209.2021.1893349 |
| 英文摘要 | ContextCapsule of alkaloids from the leaf of Alstonia scholaris (L.) R.Br. (Apocynaceae) (CALAS) is a new investigational botanical drug (No. 2011L01436) for bronchitis, post-infectious cough and asthma.ObjectiveTo observe the clinical safety and tolerability of CALAS.Materials and methodsSubjects were assigned to eight cohorts, and each received randomly CALAS or placebo in one of single ascending dose (SAD) of 8, 40, 120, 240, 360, 480, or in one of multiple ascending dose (MAD) of 40 or 120 mg, three times daily for 7 days. Each cohort contained two placebo subjects.ResultsSixty-two enrolled volunteers completed the study and no serious adverse events and clinically significant changes in vital signs, electrocardiography, and upper abdominal Doppler ultrasonography were observed. The ratios of treatment-emergent adverse events (TEAEs) were reported in 11/46 (23.91%) of CALAS groups and 3/16 (18.75%) of the placebo group (p > 0.05), respectively, based on the results of SAD and MAD. All TEAEs were mild, transient, and disappeared without any intervention. The TEAEs possibly related to CALAS treatment were as followings: hiccups (4/46: 8%), dry mouth and nausea (3/46: 6%), increased sleep (2/46: 4%), abdominal distension (1/46: 2%), bilirubin elevated (1/46: 2%).Discussion and conclusionsCALAS is safe and well-tolerated with no unexpected or clinically relevant safety concerns up to a single dose of 360 mg and three times daily for 7 days up to 120 mg in healthy Chinese volunteers, supporting further Phase II studies. |
| WOS记录号 | WOS:000644568700001 |
| 源URL | [http://ir.kib.ac.cn/handle/151853/73694]  |
| 专题 | 中国科学院昆明植物研究所 |
| 作者单位 | 1.Yunnan Univ, Yunnan Prov Ctr Res & Dev Nat Prod, Kunming, Yunnan, Peoples R China 2.[Zhao, Yun-Li 3.Chinese Acad Sci, Kunming Inst Bot, State Key Lab Phytochem & Plant Resources West Ch, Kunming 650201, Yunnan, Peoples R China 4.Yunnan Univ, Minist Educ, Key Lab Med Chem Nat Resource, Kunming, Yunnan, Peoples R China 5.Yunnan Univ, Sch Chem Sci & Technol, Kunming 650091, Yunnan, Peoples R China 6.[Gou, Zhong-Ping 7.Zou, Lin-Ling 8.Wang, Ying 9.Shu, Shi-Qing 10.Zhu, Xiao-Hong |
| 推荐引用方式 GB/T 7714 | Gou,Zhong-Ping,Zhao,Yun-Li,Zou,Lin-Ling,et al. The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial[J]. PHARMACEUTICAL BIOLOGY,2021,59(1):484-493. |
| APA | Gou,Zhong-Ping.,Zhao,Yun-Li.,Zou,Lin-Ling.,Wang,Ying.,Shu,Shi-Qing.,...&Feng,Ping.(2021).The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial.PHARMACEUTICAL BIOLOGY,59(1),484-493. |
| MLA | Gou,Zhong-Ping,et al."The safety and tolerability of alkaloids from Alstonia scholaris leaves in healthy Chinese volunteers: a single-centre, randomized, double-blind, placebo-controlled phase I clinical trial".PHARMACEUTICAL BIOLOGY 59.1(2021):484-493. |
入库方式： OAI收割
来源：昆明植物研究所
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