Department of Phase I Clinical Trial Unit, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangdong, China.
Department of Pharmacy, The Fifth Affiliated Hospital of Guangzhou Medical University, Guangdong, China.
Clin Pharmacol Drug Dev. 2023 May;12(5):518-524. doi: 10.1002/cpdd.1221. Epub 2023 Jan 29.
SAL001, a recombinant form of parathyroid hormone, is a biosimilar drug to teriparatide and is planned to be used in osteoporosis treatment. A single-dose, randomized, open-label, 2-way crossover trial was conducted in healthy subjects to compare the pharmacokinetics (PK) and safety between SAL001 and the reference drug. Sixty-four subjects were enrolled in the study, and 61 subjects completed the study. In each period, 20 μg of the test or reference formulation was administered subcutaneously. SAL001 was administered by autoinjector pen, whereas the reference drug was administered by a self-matched injection pen. Serial blood samples were obtained for the analyses of PK and serum calcium concentration. Geometric mean ratios with 90%CIs for the maximum plasma concentration (C ) and area under the plasma concentration-time curve (AUC) were estimated. The safety of these 2 formulations was also evaluated. Overall, the 90%CIs for the geometric mean ratios of C , AUC from time 0 to the last quantifiable time point, and AUC from time 0 extrapolated to infinity of the test or reference product were within 80.0%-125.0% of biosimilarity criteria. Other PK parameters, serum calcium concentration, and safety profiles had no significant differences between the 2 formulations. SAL001 demonstrated PK similarity to the reference drug, and the serum calcium concentration and safety profiles of SAL001 were also considered comparable to the reference drug.
SAL001 是一种重组甲状旁腺激素形式，是与特立帕肽生物类似的药物，计划用于骨质疏松症的治疗。在健康受试者中进行了一项单次、随机、开放标签、2 向交叉试验，以比较 SAL001 和参比药物的药代动力学（PK）和安全性。该研究纳入了 64 名受试者，其中 61 名受试者完成了研究。每个周期，皮下给予 20μg 的试验或参比制剂。SAL001 通过自动注射器笔给药，而参比药物通过自匹配注射笔给药。为了分析 PK 和血清钙浓度，采集了一系列血样。使用 90%置信区间（CI）估算了最大血浆浓度（C ）和血浆浓度-时间曲线下面积（AUC）的几何均数比值。还评估了这两种制剂的安全性。总体而言，测试或参比产品的 C 、从 0 到最后可量化时间点的 AUC 和从 0 extrapolated 到无穷大的 AUC 的几何均数比值的 90%CI 在生物类似药标准的 80.0%-125.0%范围内。其他 PK 参数、血清钙浓度和安全性特征在两种制剂之间没有显著差异。SAL001 表现出与参比药物的 PK 相似性，并且 SAL001 的血清钙浓度和安全性特征也被认为与参比药物相当。
