A Double-Masked, Randomized, Two-Treatment Cross-over Study Comparing the Pharmacokinetics of PF708 and Forteo Administered by Subcutaneous Injection in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfenex, Inc
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serum area-under-the-curve (AUC) of PF708 and Forteo
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.
详细描述
This is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects. Half of the subjects will be randomized to receive PF708 first and Forteo second (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence (Sequence B),
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18-50 years at the time of Informed Consent.
- •Able to understand and sign the written Informed Consent Form (ICF).
排除标准
- •History of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus [test for hepatitis C virus antibody (HCV Ab)] or hepatitis B virus [test for hepatitis B surface antigen (HBsAg)].
- •Female subjects who are pregnant or have a positive pregnancy test result, currently breastfeeding, or planning to become pregnant during the course of the study.
- •Blood donation (greater than or equal to 500 mL) within 30 days prior to screening.
- •History of Paget's disease of bone.
- •History of prior external beam or implant radiation therapy involving the skeleton.
- •Active urolithiasis or primary hyperparathyroidism.
- •History of alcohol or substance abuse within 3 years prior to screening.
- •Previous treatment, including for investigational purposes, with any products (e.g., Forteo, Natpara) derived from human parathyroid hormone (PTH).
研究组 & 干预措施
Sequence A
Single subcutaneous injection of two teriparatide products (PF708 and Forteo)
干预措施: Teriparatide (Drug)
Sequence B
Single subcutaneous injection of two teriparatide products (Forteo and PF708)
干预措施: Teriparatide (Drug)
结局指标
主要结局
Serum area-under-the-curve (AUC) of PF708 and Forteo
时间窗: 24 hours
Serum maximum concentration (Cmax) of PF708 and Forteo
时间窗: 24 hours
次要结局
- Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo(0-24 hours)