ABSTRACT

Background

P044 is a proposed biosimilar candidate of Teriparatide for reference medicine, Forsteo®. This study was designed to evaluate the Pharmacokinetic/Pharmacodynamic (PK/PD) bioequivalence between P044 and Forsteo®.

Methods

In this randomized, open-label, single-dose, crossover study, 66 healthy female subjects were randomized to receive P044 and Forsteo®. The primary PK endpoints of the study were the area under the concentration versus time from zero to infinity (AUC_0-inf) and maximum plasma concentration (C_max). Secondary endpoints included area under the concentration versus time from zero to the last quantifiable concentration (AUC_0-last) and C_max for PD parameter, additional PK parameters and safety.

Results

Sixty-six subjects were enrolled in the study and baseline demographics were similar between the two treatments. The two treatments presented similar PK/PD parameters and the 90% confidence interval for primary and secondary endpoints were within the bioequivalence acceptance range (80.00–125.00%) for all parameters. None of the subjects experienced serious adverse event, and all of the reported adverse events were mild and similar between two treatments.

Conclusions

This study demonstrated the PK/PD similarity of P044 to reference medicine, Forsteo® and safety profiles were comparable between treatments.

Trial Registration

EudraCT Number: 2019–004477-82

中文翻译：

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一项随机药代动力学/药效学研究，比较潜在生物仿制药候选 P044 与参考药物在健康志愿者中的生物等效性

摘要

背景

P044 是特立帕肽（Teriparatide）的拟议生物仿制药候选药物，用于参考药物 Forsteo®。本研究旨在评估 P044 和 Forsteo® 之间的药代动力学/药效学 (PK/PD) 生物等效性。

方法

在这项随机、开放标签、单剂量、交叉研究中，66 名健康女性受试者随机接受 P044 和 Forsteo®。该研究的主要 PK 终点是从零到无穷大（AUC _0-inf）和最大血浆浓度（C _max）的浓度下面积与时间的关系。次要终点包括从零到最后可量化浓度 (AUC _0-last ) 的浓度下面积与时间的关系以及 PD 参数、附加 PK 参数和安全性的 C _max。

结果

66 名受试者参加了这项研究，两种治疗方法的基线人口统计数据相似。两种治疗方法的 PK/PD 参数相似，主要和次要终点的 90% 置信区间在所有参数的生物等效性接受范围 (80.00–125.00%) 内。没有受试者经历严重的不良事件，并且所有报告的不良事件都是轻微的并且在两种治疗之间相似。

结论

该研究表明 P044 与参考药物 Forsteo® 的 PK/PD 相似性和安全性在治疗之间具有可比性。

试用注册

EudraCT编号：2019-004477-82