PDF(Pubmed)
Abstract：
BACKGROUND: Interleukin-17A (IL-17A) plays a crucial role in the pathogenesis of ankylosing spondylitis (AS), although not all patients respond to traditional IL-17A antibody treatments. QX002N injection, as a new monoclonal antibody targeting IL-17A, has shown potential in treating AS, offering a new treatment option for patients who do not respond well to existing therapies.
METHODS: A randomized, open, parallel, single-center, phase I study was conducted to assess the pharmacokinetics, safety, and immunogenicity of single doses of QX002N injection administered intravenously (IV) or subcutaneously (SC) to healthy Chinese volunteers. Blood samples were collected at specified time intervals, and then serum concentrations of QX002N were analyzed by enzyme-linked immunosorbent assay.
RESULTS: Pharmacokinetic analysis of the drug concentration-time data showed that the mean maximum observed serum QX002N concentration (Cmax) was 110 and 33.9 µg/ml, respectively. The average area under the drug concentration-time curves from 0 to the time of the last quantifiable concentration (AUClast) were 52,656 and 36,269 µg·h/ml, respectively and the average area under the drug concentration-time curves from 0 to infinity (AUCinf) were 54,867 and 38,194 µg·h/ml, respectively. The absolute bioavailability of QX002N after SC injection was 69.6%.
CONCLUSIONS: Immunogenicity was assessed and all the subjects in this study were Anti-drug antibody (ADA)-negative, which means no subjects appeared to develop immunogenicity to QX002N. All the results testify to the safety of QX002N injection, which is satisfactory after IV or SC dosing in healthy subjects.
BACKGROUND: www.chinadrugtirals.org.cn , CTR20220430.
METHODS: A randomized, open, parallel, single-center, phase I study was conducted to assess the pharmacokinetics, safety, and immunogenicity of single doses of QX002N injection administered intravenously (IV) or subcutaneously (SC) to healthy Chinese volunteers. Blood samples were collected at specified time intervals, and then serum concentrations of QX002N were analyzed by enzyme-linked immunosorbent assay.
RESULTS: Pharmacokinetic analysis of the drug concentration-time data showed that the mean maximum observed serum QX002N concentration (Cmax) was 110 and 33.9 µg/ml, respectively. The average area under the drug concentration-time curves from 0 to the time of the last quantifiable concentration (AUClast) were 52,656 and 36,269 µg·h/ml, respectively and the average area under the drug concentration-time curves from 0 to infinity (AUCinf) were 54,867 and 38,194 µg·h/ml, respectively. The absolute bioavailability of QX002N after SC injection was 69.6%.
CONCLUSIONS: Immunogenicity was assessed and all the subjects in this study were Anti-drug antibody (ADA)-negative, which means no subjects appeared to develop immunogenicity to QX002N. All the results testify to the safety of QX002N injection, which is satisfactory after IV or SC dosing in healthy subjects.
BACKGROUND: www.chinadrugtirals.org.cn , CTR20220430.
摘要：
背景：白细胞介素-17A（IL-17A）在强直性脊柱炎（AS）的发病机制中起着至关重要的作用，尽管并非所有患者都对传统的IL-17A抗体治疗有反应。QX002N进样,作为一种新的靶向IL-17A的单克隆抗体，已经显示出治疗AS的潜力，为对现有疗法反应不佳的患者提供新的治疗选择。
方法：随机，打开,平行,单中心,进行了I期研究以评估药代动力学，安全,和单剂量的QX002N注射液静脉内（IV）或皮下（SC）给予健康的中国志愿者的免疫原性。在指定的时间间隔收集血样，然后通过酶联免疫吸附试验分析QX002N的血清浓度。
结果：药物浓度-时间数据的药代动力学分析表明，平均最大观察到的血清QX002N浓度（Cmax）为110和33.9µg/ml，分别。从0到最后可量化浓度（AUClast）的时间，药物浓度-时间曲线下的平均面积分别为52,656和36,269µg·h/ml，从0到无穷大的药物浓度-时间曲线下的平均面积（AUCinf）分别为54,867和38,194µg·h/ml，分别。SC注射后QX002N的绝对生物利用度为69.6%。
结论：评估了免疫原性，本研究中的所有受试者均为抗药物抗体（ADA）阴性，这意味着没有受试者出现对QX002N的免疫原性。所有结果都证明了QX002N注射液的安全性，在健康受试者中IV或SC给药后是令人满意的。
背景：www.chinadrugtirals.org.cn,CTR20220430。
方法：随机，打开,平行,单中心,进行了I期研究以评估药代动力学，安全,和单剂量的QX002N注射液静脉内（IV）或皮下（SC）给予健康的中国志愿者的免疫原性。在指定的时间间隔收集血样，然后通过酶联免疫吸附试验分析QX002N的血清浓度。
结果：药物浓度-时间数据的药代动力学分析表明，平均最大观察到的血清QX002N浓度（Cmax）为110和33.9µg/ml，分别。从0到最后可量化浓度（AUClast）的时间，药物浓度-时间曲线下的平均面积分别为52,656和36,269µg·h/ml，从0到无穷大的药物浓度-时间曲线下的平均面积（AUCinf）分别为54,867和38,194µg·h/ml，分别。SC注射后QX002N的绝对生物利用度为69.6%。
结论：评估了免疫原性，本研究中的所有受试者均为抗药物抗体（ADA）阴性，这意味着没有受试者出现对QX002N的免疫原性。所有结果都证明了QX002N注射液的安全性，在健康受试者中IV或SC给药后是令人满意的。
背景：www.chinadrugtirals.org.cn,CTR20220430。
