An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- PK AUC1
研究概览
简要总结
A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women
详细描述
This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.
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
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 40 to 65 years old, inclusive, at Screening;
- •Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 32 kg/m^2;
- •Laboratory test results within the normal range
- •Serum 25-hydroxyvitamin D values must be > 20 ng/mL.
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study;
- •Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
- •History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
- •History of allergy to abaloparatide or drugs in a similar pharmacological class;.
研究组 & 干预措施
abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2)
Abaloparatide-SC injection (Period 1) followed by abaloparatide-sMTS application (Period 2). Abaloparatide-SC is a drug-device combination product consisting of abaloparatide, an active synthetic peptide analog of parathyroid hormone related peptide (PTHrP), administered to the periumbilical region via an injection pen. Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide.
干预措施: abaloparatide-sMTS (Combination Product)
abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2)
Abaloparatide-SC injection (Period 1) followed by abaloparatide-sMTS application (Period 2). Abaloparatide-SC is a drug-device combination product consisting of abaloparatide, an active synthetic peptide analog of parathyroid hormone related peptide (PTHrP), administered to the periumbilical region via an injection pen. Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide.
干预措施: abaloparatide-SC (Combination Product)
Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2)
Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2).
干预措施: abaloparatide-sMTS (Combination Product)
Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2)
Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2).
干预措施: abaloparatide-SC (Combination Product)
结局指标
主要结局
PK AUC1
时间窗: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
PK AUC2
时间窗: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
PK Cmax
时间窗: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Maximum observed concentration (Cmax)
次要结局
- Subjects with AEs and SAEs(10 Days)