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Randomized, double-blind, placebo-controlled, multiple-dose study of the safety, tolerability and pharmacokinetics of benvitimod, a candidate drug for the treatment of psoriasis
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
2014-08-01
DOI10.1111/jcpt.12158
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
WOS记录号WOS:000339428100014
项目编号2012ZX09303019
资助机构major project of National Science and Technology "creation of major new drugs"
引用统计
被引频次:2[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/50593
专题北京大学第二临床医学院_药剂科
北京大学第二临床医学院_产科
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
推荐引用方式
GB/T 7714
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.
APA Zhao, L..,Chen, X..,Cai, L..,Zhang, C..,Wang, Q..,...&Fang, Y..(2014).Randomized, double-blind, placebo-controlled, multiple-dose study of the safety, tolerability and pharmacokinetics of benvitimod, a candidate drug for the treatment of psoriasis.JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS,39(4),418-423.
MLA Zhao, 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".JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS 39.4(2014):418-423.
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