一个I期临床研究,以评估快速,大容量,皮下自注射器耐受性与复合人体氨酸酶
David W Kang1,2, Robert J Connor3, Tara Nekoroski4
1Halozyme Therapeutics, Inc. (Innovation Department), San Diego, CA, USA. publications@halozyme.com.
Drug delivery and translational research
|May 30, 2025
概括
一种新的高容量自注射器 (HVAI) 成功地将10毫升的免疫球蛋白G (IgG) 与复合人体氨酶PH20 (rHuPH20) 安全地输送. 这种快速的皮下注射技术被健康的受试者容忍得很好.
科学领域:
- 药理学 药理学是指药理学的学科.
- 生物技术是生物技术.
- 临床试验 临床试验
背景情况:
- 从历史上看,手持自动注射器 (AI) 仅限于≤2毫升的体积.
- 快速高容量AI (HVAI) 的开发可以提供更大的治疗容量.
- 重组人体氨酶PH20 (rHuPH20) 促进皮下药物吸收.
研究的目的:
- 评估10%免疫球蛋白G (IgG) 与rHuPH20联合配制的皮下 (SC) 注射的耐受性和安全性.
- 为了评估一个原型快速高容量自动注射器 (HVAI) 的性能.
- 通过注射器进行SC注射输送与原型HVAI进行比较.
主要方法:
- 第I阶段,在健康受试者中进行开放标签研究.
- 通过注射器,用rHuPH20注射5毫升或10毫升10%IgG.
- 通过原型HVAI在10mL/30秒内输送10mL的10%IgG与rHuPH20.
主要成果:
- 所有注射都被很好地容忍,没有严重的不良事件 (AE).
- 与注射器 (25%) 相比,治疗出现的副作用是轻微的,并且在HVAI给药时发生的频率较低 (17%).
- 平均HVAI注射持续时间为27.9秒;91%的人报告没有/轻度注射部位疼痛.
结论:
- 使用原型HVAI进行10%IgG与rHuPH20的皮下注射是安全的,耐受性良好.
- 在大约30秒内,HVAI证明了有效的10毫升的输送.
- 这项技术有望通过快速SC注射来管理更大容量的生物药物.
相关概念视频
Insulin Formulations: Types and Delivery
663
Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
Short-acting insulins are divided into...
Short-acting insulins are divided into...
663
Drug Accumulation During Multiple Dosing: Repetitive IV Injections
256
Calculating drug dosage and accumulation in multiple-dose regimens is crucial for achieving therapeutic efficacy while avoiding toxicity. This involves determining the plasma drug concentrations over time to optimize dosing schedules. The principle of superposition is fundamental in this process, allowing for the prediction of drug concentration in plasma following multiple doses based on single-dose data.The principle of superposition asserts that the plasma concentration-time curves from...
256
Insulin: Dosing Regimen and Adverse Effects
695
Insulin-replacement therapy usually includes both long-acting insulin (basal) and short-acting insulin (to cater to postprandial needs). In a diverse group of type 1 diabetes patients, the average daily insulin dose is typically 0.5-0.7 units/kg body weight. However, obese patients and pubertal adolescents may need more due to insulin resistance.
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
695


