NCT03974776已完成1 期
A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF-06946860 TO HEALTHY ADULT JAPANESE PARTICIPANTS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Incidence of participants experiencing AE
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult Japanese participants following single dose administration.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
- •Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- •Subjects enrolling as Japanese must have four biologically Japanese grandparents born in Japan.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
- •History of allergic reactions to diagnostic or therapeutic protein or human albumin.
- •History of recurrent infections or active infection within 28 days of screening.
- •Exposure to live vaccines within 28 days of screening.
- •History of regular alcohol consumption or positive drug test
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
- •Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose
结局指标
主要结局
Incidence of participants experiencing AE
时间窗: Up to 20 weeks post-dose
次要结局
- Maximum Observed PF-06946860 Concentration (Cmax)(Up to 20 weeks post-dose)
- PF-06946860 Half-Life (t1/2)(Up to 20 weeks post-dose, as data permit)
- Area Under the Curve From Time Zero to Last Quantifiable PF-06946860 Concentration (AUClast)(Up to 20 weeks post-dose)
- Time to Reach Maximum Observed PF-06946860 Concentration (Tmax)(Up to 20 weeks post-dose)
- Incidence of development of ADA, and if necessary NAb, against PF-06946860(Up to 20 weeks post-dose, as data permit)
研究者
研究点 (2)
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