A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- PK evaluation: Tmax
研究概览
简要总结
This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis
详细描述
This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of AK111 in subjects with moderate-to-severe 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe plaque-type psoriasis diagnosed for at least 6 months;
- •Subjects with moderate-to-severe plaque psoriasis at baseline, who were defined as follows: Body Surface Area (BSA) ≥ 10%, PASI ≥ 12 and SPGA score ≥ 3;
- •Subjects with a history of systemic therapy or phototherapy for psoriasis at least once before, or suitable to receive systemic therapy or phototherapy for psoriasis assessed by investigator;
- •Women of childbearing age is not pregnant or lactating, and the subjects and their partners voluntarily take contraceptive measures considered effective by the investigator during the treatment period and at least 6 months after the last receipt of the study drug.
排除标准
- •Forms of psoriasis other than chronic plaque-type psoriasis;
- •History or evidence of active/latent tuberculosis;
- •Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening;
- •History of serious infection within 2 months before screening;
- •History of malignancy of any organ system;
- •Inadequate washout period for prior psoriatic therapy;
- •Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor;
- •Any medical conditions, in the opinion of the investigator, would place the subject at risk, interfere with study participation or study results interpretation.
研究组 & 干预措施
AK111 regimen
干预措施: AK111 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
PK evaluation: Tmax
时间窗: Baseline till week 20
Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.
PK evaluation: AUC
时间窗: Baseline till week 20
Assessment of area under curve (AUC) after AK111 administration.
Assessment of Safety
时间窗: Baseline till Week 20
Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).
PK evaluation: T1/2
时间窗: Baseline till week 20
Assessment of elimination half-life (T1/2) after AK111 administration.
PK evaluation: Cmax
时间窗: Baseline till week 20
Assessment of maximum plasma concentration (Cmax) after AK111 administration.
次要结局
- PASI 75(At week 12)
- sPGA 0/1(At week 12)
- PASI 90(At week 12)
- Immunogenicity(Baseline till week 20)
- PASI 100(At week 12)