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Clinical Trials associated with Skin Prick Solution for Platanus Acerifolia Pollen (Wolwo Bio-Pharmaceutical)一项在中国过敏受试者中同时进行多种变应原点刺液试验有效性及安全性的临床研究
[Translation] A clinical study on the efficacy and safety of simultaneous multi-allergen spot prick test in Chinese allergic subjects
根据《药物临床试验质量管理规范》和药物临床试验批件(批件号2017L04056、2017L04057、2017L04059、2017L04061、2017L04054)要求,申办方希望通过开展一项多中心、开放的III期临床试验,考察过敏受试者在多种变应原点刺液合用时的有效性及安全性,并评价利益与风险关系,最终为变应原点刺液的注册申请提供充分的依据。
[Translation] In accordance with the Good Clinical Practice Guidelines for Drugs and the drug clinical trial approval documents (approval numbers 2017L04056, 2017L04057, 2017L04059, 2017L04061, and 2017L04054), the sponsor hopes to conduct a multicenter, open Phase III clinical trial to examine the effectiveness and safety of multiple allergen spot prick solutions in allergic subjects, evaluate the relationship between benefits and risks, and ultimately provide sufficient basis for the registration application of the allergen spot prick solution.
一项在中国志愿者中探索同时进行多种变应原点刺液试验耐受性的临床研究
[Translation] A clinical study exploring the tolerance of simultaneous multi-allergen spot prick tests in Chinese volunteers
本研究通过在同一个过敏志愿者身上同时进行8种变应原点刺液的试验,考察两剂量组组志愿者分别在相应的剂量组下对8种变应原点刺液合用的耐受性,为此8种变应原点刺液后续大规模临床试验的设计提供依据。
[Translation] This study simultaneously tested eight allergen spot-prick solutions on the same allergic volunteer to examine the tolerance of volunteers in two dose groups to the combined use of eight allergen spot-prick solutions at the corresponding dose groups, providing a basis for the design of subsequent large-scale clinical trials of the eight allergen spot-prick solutions.
一项在中国志愿者中探索多种变应原点刺液安全性及有效性的临床研究
[Translation] A clinical study exploring the safety and efficacy of multi-allergen spot prick in Chinese volunteers
本研究通过在同一个过敏受试者身上进行单一变应原点刺液3种不同剂量的梯度试验,考察一定剂量范围内受试者对相应变应原的耐受性,及各剂量下的皮肤点刺试验阳性情况,为8种变应原点刺液后期临床有效剂量探索提供参考,为本研究所有试验药物注册申请审查提供依据。
[Translation] This study conducted a gradient test of three different doses of a single allergen prick solution on the same allergic subject to examine the subjects' tolerance to the corresponding allergens within a certain dose range and the positivity of the skin prick test at each dose, providing a reference for the later clinical effective dose exploration of eight allergen prick solutions and a basis for the review of registration applications for all experimental drugs in this study.
100 Clinical Results associated with Skin Prick Solution for Platanus Acerifolia Pollen (Wolwo Bio-Pharmaceutical)
100 Translational Medicine associated with Skin Prick Solution for Platanus Acerifolia Pollen (Wolwo Bio-Pharmaceutical)
100 Patents (Medical) associated with Skin Prick Solution for Platanus Acerifolia Pollen (Wolwo Bio-Pharmaceutical)
100 Deals associated with Skin Prick Solution for Platanus Acerifolia Pollen (Wolwo Bio-Pharmaceutical)