首页> 外文OA文献 >Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double‐blind, parallel‐controlled, phase 1 study

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Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double‐blind, parallel‐controlled, phase 1 study

机译：HLX03的药代动力学，安全性和免疫原性，一种Adalimalab生物仿生，与健康中国男性志愿者的参考生物制剂相比：随机，双盲，平行控制，第1期研究结果

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Hong Zhang; Min Wu; Jixuan Sun; Xiaoxue Zhu; Cuiyun Li; Yanhua Ding; Xiaodi Zhang; Katherine Chai; Xiaojiao Li;
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1. A randomized, double-blind, single-dose, two-arm, parallel study comparing pharmacokinetics, immunogenicity and tolerability of branded adalimumab and its biosimilar LBAL in healthy male volunteers [J] . Park Kyoung Ryun, Chung Hyewon, Yang Sung Mo, Expert opinion on investigational drugs . 2017,第1a6期

机译：随机，双盲，单剂量，双臂，并行研究比较了品牌Adalimalab的药代动力学，免疫原性和耐受性及其在健康男性志愿者中的生物仿制性LBAL
2. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE (R)-PK) in healthy subjects [J] . Wynne Christopher, Altendorfer Mario, Sonderegger Ivo, Expert opinion on investigational drugs . 2016,第12期

机译：在健康受试者的一项随机，双盲，活性比较剂I期临床研究（VOLTAIRE（R）-PK）中，阿达木单抗生物仿制药BI 695501与参考生物制剂相比，其生物等效性，安全性和免疫原性
3. A large multicentre, randomized, double‐blind, cross‐over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US‐ and EU‐reference biologics [J] . Anne Bellon, Jessie Wang, Andrej Skerjanec, British journal of clinical pharmacology . 2020,第6期

机译：健康志愿者的大型多方面，随机，双盲，交叉研究，以比较Pegfilgrastim BioSimilar与其和欧盟参考生物制剂的药代动力学，药效学和安全性
4. A Phase I, Double-Blind, Randomized, Dose Escalating Crossover Study ofan Oral Formulation of Human Growth Hormone in Healthy Male Volunteers [C] . Steven M. Dinh, Puchun Liu, Ehud Arbit, Controlled Release Society annual meeting . 2004

机译：健康男性志愿者中人类生长激素口服制剂的I期，双盲，随机，剂量递增交叉研究
5. Efficacy of the Chinese herbal formula CUF2 in the treatment of childhood asthma: Animal experiment, in vitro study and randomized, double-blinded, placebo-controlled clinical trial. [D] . Wong, Yeuk Oi. 2006

机译：中药配方CUF2在治疗儿童哮喘中的功效：动物实验，体外研究以及随机，双盲，安慰剂对照的临床试验。
6. Pharmacokinetics safety and immunogenicity of HLX03 an adalimumab biosimilar compared with reference biologic in healthy Chinese male volunteers: Results of a randomized double‐blind parallel‐controlled phase 1 study [O] . Hong Zhang, Min Wu, Jixuan Sun, 2021

机译：HLX03的药代动力学安全性和免疫原性一种Adalimalab生物仿生与健康中国男性志愿者的参考生物制剂相比：随机双盲平行控制第1期研究结果
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机译：与在健康受试者的随机检测，双盲，活性比较剂阶段I临床研究（Voltaire®-PK）中的参考生物学相比，Bi 695501的生物等级，安全性和免疫原性。
8. Randomized Double-Blind Phase III Pivotal Field Trial of the Comparative Immunogenicity Safety and Tolerability of Two Yellow Fever 17D Vaccines (ARILVAX(Trademark) and YF-VAX(Trademark)) in Healthy Infants and Children in Peru [R] . Belmusto-Worn, V. E. , Sanchez, J. L. , McCarthy, K. , 2004

机译：秘鲁健康婴儿和儿童两种黄热病17D疫苗（aRILVaX（商标）和YF-VaX（商标））的比较免疫原性安全性和耐受性的随机双盲III期关键现场试验

Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double‐blind, parallel‐controlled, phase 1 study

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