A Phase 1, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single or Multiple Subcutaneous Doses of Lyophilized Formulation of Recifercept in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time to Reach Maximum Observed Plasma Concentration (Tmax)
研究概览
简要总结
This will be a single center, randomized, parallel group, repeated dose study of recifercept (Cohort 1 and Cohort 2) or placebo (only in Cohort 1) in approximately 18 healthy participants, using 2 cohorts (N = 9) at two dose levels of recifercept.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Only cohort 1 of the study is blinded.
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male participants and female participants of nonchildbearing potential
- •Participants who are overtly healthy
- •Capable of giving signed informed consent
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- •Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing
研究组 & 干预措施
Low Dose
Repeated multiple doses
干预措施: Recifercept (Drug)
placebo
Repeated multiple doses
干预措施: Placebo (Other)
High Dose
Repeated multiple doses
干预措施: Recifercept (Drug)
结局指标
主要结局
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose
Time to reach Cmax
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
时间窗: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
时间窗: 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose
Area under the concentration curve from time 0 to end of dosing interval (AUCtau)
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose
Maximum Observed Plasma Concentration directly from data
Plasma Decay Half-Life (t1/2)
时间窗: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Accumulation Ratio (Rac)
时间窗: 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1).
次要结局
- Incidence of Anti-drug antibodies (ADA)(6 months post-dose)
- Incidence of Neutralizing antibodies (NAb)(6 months post-dose)