NCT00810758已完成1 期
A Phase 1, Randomized, Placebo Controlled, Blinded (3rd Party Open), Sequential, Multiple-Dose Escalation Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691 In Healthy Volunteers
适应症
干预措施
相关药物
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
- To assess the safety and toleration of multiple ascending oral doses of PF-04878691
研究概览
简要总结
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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 male and/or female subjects between the ages of 18-55, inclusive.
- •Body Mass Index (BMI) of 18-30 kg/m2; total body weight >50kg (110lbs).
排除标准
- •Pregnant or nursing females.
- •Females of child-bearing potential.
- •Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening.
- •Smoking within the previous 6 months.
研究组 & 干预措施
PF-04878691
Experimental
干预措施: PF-04878691 3mg (Drug)
PF-04878691
Experimental
干预措施: PF-04878691 6mg (Drug)
PF-04878691
Experimental
干预措施: PF-04878691 9mg (Drug)
结局指标
主要结局
To assess the safety and toleration of multiple ascending oral doses of PF-04878691
时间窗: 3 weeks
次要结局
- To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691(3 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
DP13 SAD & MAD in Healthy Male SubjectsSafety and TolerabilityNCT03046589Damian Pharma AG48
已完成
1 期
PF-06669571 In Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseNCT02565628Pfizer20
已完成
1 期
Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy ParticipantsSafety and TolerabilityNCT05431634Alumis Inc49
已完成
1 期
A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT05437419Teijin America, Inc.32
已完成
1 期
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult VolunteersTuberculosisNCT00990990Sequella, Inc.59