A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin β4 in healthy volunteers
A randomized, placebo-controlled, single and multiple dose study of intravenous thymosin β4 in healthy volunteers
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DOI：
10.1111/j.1749-6632.2010.05474.x
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发表时间：
2010-01-01
期刊：
影响因子：
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通讯作者：
Zhang, Yuxin
中科院分区：
文献类型：
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作者：
Ruff, Dennis;Crockford, David;Zhang, Yuxin
合成胸腺素β 4 （T β 4）可能在促进急性心肌梗死期间心肌细胞存活方面具有潜在的作用。四个队列，每组10名健康受试者，给予单次静脉注射剂量的安慰剂或合成T β 4。各组接受的剂量分别为42,140,420或1260毫克。安全性审查后，受试者每天给予相同的剂量方案，持续14天。安全性评估、治疗中出现的不良事件发生率和药代动力学参数进行了评估。不良事件很少发生，且强度为轻度或中度。没有剂量限制性毒性或严重不良事件。单剂量药代动力学表现出剂量正比效应，半衰期随剂量增加而增加。合成T β 4在42- 1260mg的剂量范围内单次静脉给药或每日多次给药，持续14天，耐受性良好，无剂量限制性毒性的证据。应考虑进一步发展用于心脏缺血。
Synthetic thymosin beta 4 (T beta 4) may have a potential use in promoting myocardial cell survival during acute myocardial infarction. Four cohorts, with 10 healthy subjects each, were given a single intravenous dose of placebo or synthetic T beta 4. Cohorts received ascending doses of either 42,140,420, or 1260 mg. Following safety review, subjects were given the same dose regimen daily for 14 days. Safety evaluations, incidence of Treatment-Emergent Adverse Events, and pharmacokinetic parameters were evaluated. Adverse events were infrequent, and mild or moderate in intensity. There were no dose limiting toxicities or serious adverse events. Pharmacokinetic profile for single dose showed a dose proportional response, and an increasing half-life with increasing dose. Synthetic T beta 4 given intravenously as a single dose or in multiple daily doses for 14 days over a dose range of 42-1260 mg was well tolerated with no evidence of dose limiting toxicity. Further development for use in cardiac ischemia should be considered.