A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 4
- 主要终点
- Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose
研究概览
简要总结
The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health before randomization
- •Has a body weight between 75 and 100 kg, inclusive
- •Is assigned female sex at birth and is a participant of nonchildbearing potential (PONCBP) defined as one of the following:
- •Premenarchal
- •Premenopausal with documented hysterectomy and/or bilateral salpingectomy
- •Postmenopausal
- •Medical cause of permanent infertility (eg, Müllerian agenesis, androgen insensitivity)
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia)
- •Has had a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within 3 months prior to screening
研究组 & 干预措施
High Dose Subcutaneous Injection
Participants will receive a single subcutaneous high dose of sotatercept administered via syringe.
干预措施: Sotatercept (Biological)
High Dose Subcutaneous Autoinjector
Participants will receive a single subcutaneous high dose of sotatercept administered via autoinjector.
干预措施: Sotatercept Autoinjector (Biological)
Low Dose Subcutaneous Autoinjector
Participants will receive a single subcutaneous low dose of sotatercept administered via autoinjector.
干预措施: Sotatercept Autoinjector (Biological)
结局指标
主要结局
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose
时间窗: Predose and at designated timepoints (up to approximately 120 days postdose)
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose
时间窗: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Maximum Observed Concentration (Cmax) of Sotatercept at High Dose
时间窗: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
次要结局
- Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Sotatercept at High Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- Cmax of Sotatercept Low Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- Tmax of Sotatercept at Low Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- AUC0-inf of Sotatercept at Low Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- AUC0-last of Sotatercept at Low Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- t1/2 of Sotatercept at Low Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- CL/F of Sotatercept at Low Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- Vz/F of Sotatercept at Low Dose(Predose and at designated timepoints (up to approximately 120 days postdose)
- Number of Participants who Experienced an Adverse Event (AE)(Up to approximately 120 days)
- Number of Participants who Discontinued the Study Due to an AE(Up to approximately 120 days)