NCT03599063已完成1 期
A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF 06946860 TO HEALTHY ADULT SUBJECTS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 63
- 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 subjects following single ascending doses This is the first clinical study of PF-06946860.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 9 weeks post dose
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Baseline, up to 9 weeks post dose, as data permit)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Baseline, up to 9 weeks post dose, as data permit)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Baseline, up to 9 weeks post dose, as data permit)
- Incidence of development of ADA, and if necessary NAb, against PF-06946860(Baseline, up to 9 weeks post-dose, as data permit)
- Plasma Decay Half-Life (t1/2)(Baseline, up to 9 weeks post dose, as data permit)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Singe Dose Study of PF- 06946860 in Healthy Adult Japanese ParticipantsHealthyNCT03974776Pfizer8
已完成
1 期
A Study of PF-07258669 In Healthy Adult ParticipantsHealthy ParticipantsNCT05113940Pfizer120
已完成
1 期
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy VolunteersHealthy VolunteersNCT00797342Pfizer27
已完成
1 期
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy VolunteersHealthyNCT02228395Biogen12
已完成
1 期
A Study To Evaluate the Safety, Tolerability, And Pharmacokinetics Of PF-06266047 In Healthy Adult SubjectsHealthy VolunteersNCT02539550Pfizer25