Safety, Tolerability and Pharmacokinetics Studies Following Multiple Subcutaneous Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability]
研究概览
简要总结
This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis.
The primary objective of this study is to investigate the safety and tolerability of multiple doses of subcutaneous SHR-1314 in subjects with moderate-to-severe plaque psoriasis. Secondary objectives are to determine the pharmacokinetics (PK) and immunogenicity profile of SHR-1314 in subjects with moderate-to-severe plaque psoriasis.
详细描述
16 subjects with 2 dose groups will be enrolled in the study, all of whom received the SHR-1314 without placebo control. There are 8 subjects in each cohort. The dose will be started at 160mg and will be escalated by following dose escalating rules. The primary endpoint is the safety and tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female at age between 18 and 65 years old at screening.
- •History of chronic plaque-type psoriasis for at least 6 months, with either documented medical history of psoriasis for at least 6 months or confirmation of the diagnosis by the Investigator at screening, if the subject was diagnosed by another physician.
- •At the time of randomization, moderate to severe plaque psoriasis, defined by:
- •PASI score of 12 or greater and
- •PGA score of 3 or greater and
- •BSA affected by plaque-type psoriasis of 10% or greater.
- •A subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
- •Body Mass Index (BMI) of 18 to 35 kg/m2 (inclusive) at screening.
排除标准
- •Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate psoriasis) at screening.
- •Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization.
- •Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior to randomization.
- •History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
- •At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •History of depression and/or suicidal ideation or any suicidal behavior based on clinical assessment by the investigator.
- •Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
- •Are currently enrolled in, or discontinued from a clinical trial involving an IP within the last 4 weeks or at least 5 half-lives of the last dosing prior to randomization, whichever is longer; or concurrently enrolled (at randomization) in any other trials.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test at screening or Day
- •Females of childbearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use highly effective contraception during the study and 21 weeks after the last administration of IP (anticipated 5 half-lives).
- •History of alcohol or illicit drug abuse within the year prior to screening.
- •Have any other condition that precludes the subject from following and completing the protocol, in the opinion of the Investigator.
研究组 & 干预措施
Cohort 1
Multiple subcutaneous injections of SHR-1314 at 160mg every two weeks
干预措施: SHR-1314 (Biological)
Cohort 2
Multiple subcutaneous injections of SHR-1314 at 240mg every two weeks
干预措施: SHR-1314 (Biological)
结局指标
主要结局
Incidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability]
时间窗: Baseline to 168 days after first dose administration
Incidence and severity of adverse events, change from baseline in vital signs and 12-lead electrocardiogram.
Incidence of development of Anti-drug Antibodies (ADAs) [Safety and Tolerability]
时间窗: Baseline to 168 days after first dose administration
Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.
次要结局
- Assessment of development of Anti-drug Antibodies (ADAs)(Baseline to 168 days after first dose administration)
- Assessment of PK parameter(Baseline to 168 days after first dose administration)