跳至主要内容
临床试验/NCT02045732
NCT02045732终止1 期

A Phase 1b, Double-blinded, Placebo-controlled, Randomized Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Subjects With Multiple Sclerosis (ms)

Pfizer16 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
1 期
状态
终止
发起方
Pfizer
入组人数
4
试验地点
16
主要终点
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs

研究概览

简要总结

PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the progression of the disease.

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

入选标准

  • Women and men aged 18-55 yrs.
  • Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2010 revision of the McDonald Criteria.
  • Expanded Disability Status Scale (EDSS) between 0-5, inclusive.

排除标准

  • Relapse episode of MS within 2 weeks of enrollment.
  • Primary progressive MS without a relapsing component.
  • Intolerant or unwilling to undergo MRI scanning. Treatment with disease modifying agents up to 6 weeks prior to enrollment.

结局指标

主要结局

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs

时间窗: Baseline through Day 127/Early Termination

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.

Number of Treatment-Emergent AEs and SAEs by Severity

时间窗: Baseline through Day 127/Early Termination

AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.

Number of Participants With Clinical Laboratory Abnormalities

时间窗: Baseline through Day 127/Early Termination

Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (\<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (\>=)1; urine nitrite \>=1; urine leukocyte esterase \>=1; urine red blood cell (RBC) \>=20/high-power field (HPF).

Number of Participants With Clinically Significant Changes in Vital Signs

时间窗: Baseline through Day 127/Early Termination

Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of \<90 millimeters of mercury (mm Hg) or change in supine SBP of \>=30 mm Hg; supine diastolic blood pressure (DBP) of \<50 mm Hg or change in supine DBP of \>=20 mm Hg; supine pulse rate of \<40 or more than (\>)120 beats per minute (bpm).

Number of Participants With Abnormal Electrocardiogram (ECG)

时间窗: Baseline through Day 127/Early Termination

Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) \>=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to \<60 msec and \>=60 msec.

Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)

时间窗: Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination

Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) \>=4.32.

次要结局

  • Concentration of PF-06342674(Baseline through Day 127/Early Termination)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (16)

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