NCT02207595已完成1 期
A Randomized, Investigator- and Subject-blind, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of UCB5857 in Healthy Subjects
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
- UCB Celltech
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events during the study
研究概览
简要总结
The primary objective of this study is to investigate the safety and tolerability of UCB5857.
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
- 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
- •To be eligible to participate in this study, all of the following criteria must be met:
- •An Independent Ethics Committee (IEC)-approved written Informed Consent Form is signed and dated by the subject
- •Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator
- •Subject is male or female, 18 to 55 years of age (inclusive)
- •Female subjects must have a negative pregnancy test in urine at the Screening Visit and a negative serum pregnancy test on Day -1, and be of nonchildbearing potential, defined as being:
- •Postmenopausal (for at least 2 years before the Screening Visit), verified by serum follicle-stimulating hormone (FSH) level >40 mIU/mL at the Screening Visit, or
- •Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy), or
- •Congenitally sterile
- •Contraception methods for male subjects and their female partners:
- •Male subject with a partner of childbearing potential must be willing to use a condom when sexually active
- •The female partner of childbearing potential of a male subject must be willing to use at least 2 effective methods of contraception, including a barrier method (eg, male condom, female condom, or diaphragm with spermicide) during the study period.
- •Both sexes must use the above mentioned contraception methods (condoms for males) during the study and for 20 weeks after the last administration of the Investigational Medicinal Product (IMP) (anticipated 5 half-lives).
- •Subject is of normal weight as determined by a body mass index (BMI) of 18.0 to 30.0 kg/m^2 (inclusive), with a body weight of at least 50 kg
- •Subject has clinical laboratory test results within the reference ranges of the testing laboratory
- •Subject has Blood Pressure (BP) and pulse within normal range in a supine position after 5 minutes rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse: 40 to 90 beats per minute - all inclusive)
- •Subject's ECG is considered "normal" or "abnormal but clinically nonsignificant" (as interpreted by the Investigator)
排除标准
- •Subjects are not permitted to enroll in the study if any of the following criteria is met:
- •Subject has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP)
- •Subject is considered anti-high-affinity immunoglobulin E (IgE) receptor nonresponsive if CD63 induction on basophils is <10 %
- •Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, and peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status
- •Subject has diabetes mellitus of any type requiring insulin
- •Subject has
- •an active infection (eg, sepsis, pneumonia, abscess)
- •history of latent, chronic, or recurrent infections (eg, tuberculosis [TB], recurrent sinusitis, genital herpes, urinary tract infections) or at risk of infection (surgery, trauma, infection requiring antibiotics, history of skin abscesses) within 3 months before IMP administration
- •experienced a significant episode of gastroenteritis (defined as loose stools associated with abdominal pain and/or fever) during the 7 days before IMP administration
- •When in doubt, the Investigator should confer with the Sponsor's Study Physician.
- •Subject has a history of positive TB test or evidence of possible TB or latent TB infection at the Screening Visit (QuantiFERON® Gold Test)
- •Subject has received live attenuated vaccination within 3 months or any other type of vaccine within 4 weeks before the Screening Visit or intends to have such a vaccination during the course of the study
- •Subject who has any of the following hematology values at the Screening Visit: Hemoglobin; for women <11 g/dL; for men <13 g/dL Absolute Neutrophil Count (ANC) <1.5 x 109/L (<1000/mm^3)
研究组 & 干预措施
UCB5857 Cohort 1
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: UCB5857 (Drug)
UCB5857 Cohort 1
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: Placebo (Other)
UCB5857 Cohort 2
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: UCB5857 (Drug)
UCB5857 Cohort 2
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: Placebo (Other)
UCB5857 Cohort 3
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: UCB5857 (Drug)
UCB5857 Cohort 3
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: Placebo (Other)
UCB5857 Cohort 4
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: UCB5857 (Drug)
UCB5857 Cohort 4
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: Placebo (Other)
UCB5857 Cohort 5
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: UCB5857 (Drug)
UCB5857 Cohort 5
Experimental
UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Adverse Events during the study
时间窗: Day -1 to multiple dose Day 17
次要结局
- Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- Area under the plasma concentration-time curve from time 0 to infinity (AUC)(Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose)
- The terminal elimination rate constant in plasma (λz)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- Time independency factor (TI)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- The maximum observed plasma concentration of UCB5857 after single dosing, obtained directly from the observed plasma concentration-time curves (Cmax)(Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose)
- The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- The apparent terminal half-life (t1/2)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- The apparent volume of distribution after single dosing (Vz/F)(Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose)
- The apparent total body clearance after single dosing (CL/F)(Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose)
- Mean residence time (MRT)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- The apparent volume of distribution at steady state (Vzss/F)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- The apparent total body clearance at steady state (CLss/F)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- Accumulation factor based on AUC(0-24) (RAUC)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- Basophil degranulation(Samples will be taken at Screening, SD-Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10 hours postdose) and 24, 48 hours postdose. Samples will also be taken on MD-Days 4, 8 , 13 at predose, 0.25, 0.5, 1, 2, 4, 6, 8 and 10 hours postdose)
- The maximum observed plasma concentration of UCB5857 during steady state, obtained directly from the observed plasma concentration-time curves (Cmaxss)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- The minimum observed plasma concentration of UCB5857 during steady state immediately before the next dose would be administered, obtained directly from the observed plasma concentration-time curves (Ctrough)(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
- Accumulation factor based on Cmax (R(Cmax))(Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17))
研究者
研究点 (1)
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