A Randomised, Multi-centre, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Dose Study to Assess Safety, Tolerability, PK, PD & Preliminary Efficacy of IV Doses of ONO-4685 in Patients With Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Treatment emergent adverse events (TEAEs) by severity
研究概览
简要总结
This is an early phase study to assess the safety and tolerability of ONO-4685 in patients with psoriasis. In addition, the study will assess how the drug is distributed and eliminated by the body (pharmacokinetics) and how the drug affects the body (pharmacodynamics). This will be done by measuring the amount of drug in the blood and measuring other markers in the body that might have been affected by ONO-4685. The study will also look at preliminary information on whether ONO-4685 might be effective in treating psoriasis.
The study will be split into three parts. Part A will assess a single dose of ONO-4685 in small groups of patients, each group planned to receive a higher dose than the last group. In Part B and C, patients will receive multiple doses of ONO-4685 over a period of 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double-blind study.
The pharmacist will be unblinded and is responsible for preparing blinded drug for administration.
入排标准
- 年龄范围
- 18 Years 至 65 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
- 未提供
研究组 & 干预措施
Part A, Placebo
干预措施: Placebo (Drug)
Part A, Active
干预措施: ONO-4685 (Drug)
Part B, Active
干预措施: ONO-4685 (Drug)
Part B, Placebo
干预措施: Placebo (Drug)
Part C, Active
干预措施: ONO-4685 (Drug)
Part C, Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment emergent adverse events (TEAEs) by severity
时间窗: End of Study (3 years)
Number of participants with TEAEs. An adverse event is any untoward medical occurrence in a participant who receives study drug without regard to possible causal relationship.
Clinical laboratory tests
时间窗: End of Study (3 years)
Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis).
Cytokines
时间窗: Up to day 8 post dosing day
Number of participants with elevated cytokines.
Lymphocytes
时间窗: End of Study (3 years)
Number of participants with depleted lymphocytes.
Vital signs (blood pressure)
时间窗: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (blood pressure)
Vital signs (temperature)
时间窗: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (temperature)
Vital signs (respiration rate)
时间窗: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (respiration rate)
Vital signs (pulse rate)
时间窗: End of Study (3 years)
Number of participants with clinically significant changes in vital signs (pulse rate)
ECG parameters
时间窗: End of Study (3 years)
Number of participants with ECG abnormalities.
次要结局
- Pharmacokinetics, AUC last(Part A up to day 85)
- Pharmacokinetics, AUCinf(Part A up to day 85)
- Pharmacokinetics, Cmax(Part A up to day 85, Part B and Part C up to day 113)
- Pharmacokinetics, Tmax(Part A up to day 85, Part B and Part C up to day 113)
- Pharmacokinetics (Ceoi)(Part A, Day 1 (day of dosing). Part B and C, Day 1 (day of first dose) and Day 15 or 22 (day of last dose) depending on weekly or bi-weekly dosing.)
- Pharmacokinetics, CL (Clearance)(Part A up to day 85)
- Pharmacokinetics, T1/2(Part A up to day 85, and after the last dose administration (Day 15 or 22) in Part B and Part C up to day 113.)
- Pharmacokinetics, AUCtau(Part B and C, after first (Day 1) and last (Day 15 or 22) dose)
- Pharmacodynamics, cytokines(Part A up to day 8, Part B and Part C up to day 8 post last dose)
- Immunogenicity, Anti-ONO-4685-antibodies (ADA)(Part A up to day 85, Part B and Part C up to day 113)
- Efficacy, Psoriasis Area and Severity Index (PASI)(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Psoriasis Area and Severity Index (PASI) 50(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Psoriasis Area and Severity Index (PASI) 75(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Psoriasis Area and Severity Index (PASI) 90(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Target Plaque Severity Score (TPSS)(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Physician's Global Assessment (PGA)(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Physician's Global Assessment (PGA) 0/1(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Pharmacokinetics, Vss(Part A up to day 85)
- Pharmacokinetics, Ctrough(Part B and C, prior to administration of each dose)
- Pharmacodynamics, immunoglobulin(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Patient Reported Outcome, Dermatology Life Quality Index (DLQI)(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Pharmacodynamics, lymphocytes(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Physician's Global Assessment (PGA) 0/1 and a 2-point improvement(Part A up to day 85, Part B up to day 113, Part C up to day 169)
- Efficacy, Body Surface Area (BSA)(Part A up to day 85, Part B up to day 113, Part C up to day 169)