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学科主题: 临床医学
题名:
Randomized, double-blind, placebo-controlled, multiple-dose study of the safety, tolerability and pharmacokinetics of benvitimod, a candidate drug for the treatment of psoriasis
作者: Zhao, L.1; Chen, X.1; Cai, L.2; Zhang, C.1; Wang, Q.1; Jing, S.1; Chen, G.3; Li, J.3; Zhang, J.2; Fang, Y.1
关键词: benvitimod ; healthy Chinese subjects ; multiple dose trial ; pharmacokinetics ; safety ; tolerability
刊名: JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS
发表日期: 2014-08-01
DOI: 10.1111/jcpt.12158
卷: 39, 期:4, 页:418-423
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Pharmacology & Pharmacy
研究领域[WOS]: Pharmacology & Pharmacy
关键词[WOS]: ATOPIC-DERMATITIS ; TOPICAL WBI-1001 ; EFFICACY ; TRIAL ; MILD
英文摘要:

What is known and objective: Benvitimod is a newly synthesized non-steroidal small molecule, aimed at the treatment for psoriasis. Several trials have demonstrated that benvitimod improves plaque psoriasis. However, its maximum tolerated dose and pharmacokinetic characteristics have not been reported on. The goals of this study were to evaluate the safety, tolerability and pharmacokinetics of benvitimod after topical administration in healthy subjects.

Methods: This phase I trial in healthy subjects was designed as a randomized, double-blind, placebo-controlled, ascending-dose study. After screening and randomization, 56 volunteers received benvitimod (0.5-2.0%) or placebo cream once or twice daily. Doses were escalated from 5 to 30 mg daily in six cohorts. Safety and tolerability were appraised by monitoring adverse events and laboratory parameters. Benvitimod concentrations were measured using liquid chromatography-tandem-mass spectrometry.

Results and discussion: Exposure to benvitimod did not result in electrocardiographic or clinical laboratory changes. Doses up to 30 mg were well tolerated. All adverse events were mild. Adverse effects at the application site were observed in subjects randomized to benvitimod 5 mg q.d and b.i.d, but there were no observable dose effects in the dose-range evaluated. Benvitimod was detected in fewer than 5% of the plasma samples.

What is new and Conclusions: Benvitimod cream, at single doses of up to 30 mg, is well tolerated by healthy subjects. Following topical application, systemic absorption was negligible.

语种: 英语
所属项目编号: 2012ZX09303019
项目资助者: major project of National Science and Technology "creation of major new drugs"
WOS记录号: WOS:000339428100014
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/50593
Appears in Collections:北京大学第二临床医学院_药剂科_期刊论文

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作者单位: 1.Peking Univ, Peoples Hosp, Dept Pharm, Phase Res Unit 1, Beijing 100044, Peoples R China
2.Peking Univ, Peoples Hosp, Dept Dermatol, Beijing 100044, Peoples R China
3.Celestial Pharmaceut Co Ltd, Shenzhen, Peoples R China

Recommended Citation:
Zhao, L.,Chen, X.,Cai, L.,et al. Randomized, double-blind, placebo-controlled, multiple-dose study of the safety, tolerability and pharmacokinetics of benvitimod, a candidate drug for the treatment of psoriasis[J]. JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS,2014,39(4):418-423.
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