STUDY DESIGN OF A PHASE I, PLACEBO-CONTROLLED, FIRST-INHUMAN TRIAL TO ASSESS SAFETY AND TOLERABILITY, IMMUNOGENICITY, AND PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING DOSES OF THE ANTI-ADAMTS-5 NANOBODY (R), M6495, IN HEALTHY MALE SUBJECTS

Balchen T.; Strotmann R.; Bihlet A. Reinstrup; Sonne J.; Ladel C.; Moreau F.; Guehring H.

首页> 外文期刊>Osteoarthritis and cartilage >STUDY DESIGN OF A PHASE I, PLACEBO-CONTROLLED, FIRST-INHUMAN TRIAL TO ASSESS SAFETY AND TOLERABILITY, IMMUNOGENICITY, AND PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING DOSES OF THE ANTI-ADAMTS-5 NANOBODY (R), M6495, IN HEALTHY MALE SUBJECTS

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STUDY DESIGN OF A PHASE I, PLACEBO-CONTROLLED, FIRST-INHUMAN TRIAL TO ASSESS SAFETY AND TOLERABILITY, IMMUNOGENICITY, AND PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING DOSES OF THE ANTI-ADAMTS-5 NANOBODY (R), M6495, IN HEALTHY MALE SUBJECTS

机译：研究I阶段，安慰剂控制，第一inhuman试验，以评估抗Adamts-5纳米胸（R），M6495，健康男性受试者的单一升序剂量，免疫原性和药代动力学和药效学和药效学

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《Osteoarthritis and cartilage》 |2018年第1期|共2页
作者
Balchen T.; Strotmann R.; Bihlet A. Reinstrup; Sonne J.; Ladel C.; Moreau F.; Guehring H.;
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作者单位

Bispebjerg &

Frederiksberg Hosp DanTrials ApS Copenhagen Denmark;

Merck KGaA Darmstadt Germany;

Nord BioSci Clin Dev Herlev Denmark;

Bispebjerg &

Frederiksberg Hosp Dept Clin Pharmacol Copenhagen Denmark;

Merck KGaA Darmstadt Germany;

Merck KGaA Darmstadt Germany;

Merck KGaA Darmstadt Germany;

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原文格式 PDF
正文语种 eng
中图分类骨科学（运动系疾病、矫形外科学）;
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1. STUDY DESIGN OF A PHASE I, PLACEBO-CONTROLLED, FIRST-INHUMAN TRIAL TO ASSESS SAFETY AND TOLERABILITY, IMMUNOGENICITY, AND PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING DOSES OF THE ANTI-ADAMTS-5 NANOBODY (R), M6495, IN HEALTHY MALE SUBJECTS [J] . Balchen T., Strotmann R., Bihlet A. Reinstrup, Osteoarthritis and cartilage . 2018,第Suppla1期

机译：研究I阶段，安慰剂控制，第一inhuman试验，以评估抗Adamts-5纳米胸（R），M6495，健康男性受试者的单一升序剂量，免疫原性和药代动力学和药效学和药效学
2. A Phase 1, Single-center, Double-blind, Placebo-controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Clinical Effects, and Pharmacokinetics-Pharmacodynamics of Intravenous Cyclopropyl-methoxycarbonylmetomidate (ABP-700) after a Single Ascending Bolus Dose [J] . Struys Michel M. R. F., Valk Beatrijs I., Eleveld Douglas J., Anesthesiology . 2017,第1期

机译：健康受试者中的1阶段，单中心，双盲，安慰剂对照研究，以评估单个上升推注后静脉内环丙基 - 甲氧基甲氧基羰基金属酰胺酰胺酰胺（ABP-700）的安全性，耐受性，临床效果和药代动力学 - 药效学 - 药物动力学
3. A Phase I, Single‐Ascending‐Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DS‐2969b, a Novel GyrB Inhibitor [J] . Dennie Justin, Vandell Alexander G., Inoue Satoshi, The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology . 2018,第12期

机译：I阶段，在健康受试者中进行单一升序剂量研究，以评估DS-2969B的安全性，耐受性，药代动力学，一种新型甘草抑制剂
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机译：在健康男性志愿者中单次皮下注射Teverelix储库制剂后的安全性，耐受性，药效动力学和药代动力学
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机译：1B，双盲，安慰剂控制，并行组，NGM282对结肠转运，胆汁酸痛和患者功能性便秘的粪便脂肪的药物动力学的多剂量研究
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机译：高纯度大麻二酚在健康受试者中的安全性耐受性和药代动力学的I期随机双盲安慰剂对照单次上升剂量多次剂量和食品效果试验
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机译：随机，安慰剂对照，多升级研究，以评估溶于苏拉盐环化酶刺激剂Praliciguat在健康受试者中的安全性，耐受性，药代动力学和药效学

STUDY DESIGN OF A PHASE I, PLACEBO-CONTROLLED, FIRST-INHUMAN TRIAL TO ASSESS SAFETY AND TOLERABILITY, IMMUNOGENICITY, AND PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE ASCENDING DOSES OF THE ANTI-ADAMTS-5 NANOBODY (R), M6495, IN HEALTHY MALE SUBJECTS

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