NCT02529956已完成1 期
A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis
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
- 39
- 试验地点
- 1
- 主要终点
- Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks)
研究概览
简要总结
To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method
- •Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening
- •Subject has received treatment with biologic agents within 12 months prior to the study
- •Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study
- •Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration
- •Subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic
- •Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration. When in doubt, the Investigator should confer with the UCB Study Physician
- •Subject has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening that cannot be attributed to a prior Bacillus Calmette-Guérin inoculation
- •Subject has renal or liver impairment, defined as:
- •For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or
- •ALT and aspartate aminotransferase ≥ 2x ULN, or
- •Alkaline phosphatase and bilirubin > 1.5x ULN (an isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35 %)
- •Subject has active neoplastic disease or history of neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
研究组 & 干预措施
UCB4940 8 mg
Experimental
Single intravenous (iv) infusion of UCB4940 8 mg over at least 60 minutes.
干预措施: UCB4940 (Drug)
UCB4940 40 mg
Experimental
Single intravenous (iv) infusion of UCB4940 40 mg over at least 60 minutes.
干预措施: UCB4940 (Drug)
UCB4940 160 mg
Experimental
Single intravenous (iv) infusion of UCB4940 160 mg over at least 60 minutes.
干预措施: UCB4940 (Drug)
UCB4940 480 mg
Experimental
Single intravenous (iv) infusion of UCB4940 480 mg over at least 60 minutes.
干预措施: UCB4940 (Drug)
UCB4940 640 mg
Experimental
Single intravenous (iv) infusion of UCB4940 640 mg over at least 60 minutes.
干预措施: UCB4940 (Drug)
Placebo
Placebo Comparator
Single intravenous (iv) infusion of Placebo over at least 60 minutes.
干预措施: Placebo (Other)
结局指标
主要结局
Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks)
时间窗: Baseline to 20 Weeks
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)
时间窗: Baseline to 20 Weeks
Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)
时间窗: Baseline to 20 Weeks
次要结局
- Maximum plasma concentration (Cmax)(Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20)
- Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf))(Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20)
- Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t))(Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20)
- Time to reach Cmax (Tmax)(Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20)
- Terminal elimination half-life (t1/2)(Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20)
- First order terminal elimination rate constant (λz)(Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20)
- Total body clearance (CL)(Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20)
- Volume of distribution in terminal phase (Vz)(Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20)
- Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)(Baseline to Week 12)
- Percentage Change from Baseline to Week 12 in thickness of the plaque(Baseline to Week 12)
- Percentage Change from Baseline to Week 12 in lesion area(Baseline to Week 12)
- Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)(Baseline to Week 12)
- Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA)(Baseline to Week 12)
研究者
研究点 (1)
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