A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE INTRAVENOUS AND SUBCUTANEOUS DOSES OF PF-07275315 IN HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Number of participants with clinically meaningful change from baseline in vital signs
研究概览
简要总结
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants.
This study is seeking participants who:
- Are healthy as determined by medical evaluation.
- Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square - a total body weight of more than 50 kilograms (110 pounds)
Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.
详细描述
This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple escalating doses of PF-07275315 that will be conducted in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active
PF-07275315
干预措施: PF-07275315 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with clinically meaningful change from baseline in vital signs
时间窗: Baseline through study completion, approximately 561 days
Number of participants with change from baseline in vital signs
Number of participants with Serious AEs (SAEs)
时间窗: Baseline through study completion, approximately 561 days
Incidence and severity of SAEs
Number of participants with clinically meaningful change from baseline in ECG parameters
时间窗: Baseline through study completion, approximately 561 days
number of participants with change from baseline in ECG parameters
Number of participants with Adverse Events (AEs)
时间窗: Baseline through study completion, approximately 561 days
Incidence and severity of AEs
Number of participants with clinically meaningful change from baseline in laboratory Tests Results
时间窗: Baseline through study completion, approximately 561 days
Number of Participants With Change From Baseline in Laboratory Tests Results
次要结局
- Time to Maximum Plasma Concentration (Tmax) of PF-07275315(1 - 561 Days)
- AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours(1-561 days)
- Incidence of the development of neutralizing antibodies (NAb) against PF-07275315(1-561 days)
- Maximum Plasma Concentration (Cmax)(1- 561 Days)
- Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time(1-561 days)
- Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315(1 - 561 Days)
- Incidence of the development of Antidrug antibodies (ADA) against PF-07275315(1 - 561 Days)
- Half-life of PF-07275315(1-561 days)