A Phase 1 Study to Assess the Relative PK and Tissue Distribution of Guselkumab and Risankizumab in Healthy Participants and Patients With Psoriatic Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio
研究概览
简要总结
The purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (Part 1) and psoriatic arthritis (PsA) participants (Part 2 and Part 3).
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
- None
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
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease 2019 [COVID-19]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to study intervention administration
- •Body weight within 50 kilograms (kg) to 100 kg and body mass index (BMI) within the range 18 kilograms per meter square (kg/m^2) to 30 kg/m^2 (inclusive)
- •Parts 2 and 3:
- •Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (CASPAR) at screening
- •Have active plaque psoriasis
排除标准
- •History or current signs and symptoms of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances
- •Had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or within 21 weeks after the last dose of study intervention administration
- •Parts 2 and 3:
- •History or current signs and symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
- •A nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
研究组 & 干预措施
Part 1: Healthy Participants-Coadministration
Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1.
干预措施: Guselkumab (Drug)
Part 1: Healthy Participants-Coadministration
Healthy participants will receive a single co-administered dose of risankizumab and guselkumab subcutaneously (SC) on Day 1.
干预措施: Risankizumab (Drug)
Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration
Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29.
干预措施: Guselkumab (Drug)
Part 2: Psoriatic Arthritis (PsA) Participants-Coadministration
Participants with PsA will receive a single co-administered dose of risankizumab and guselkumab SC on Day 1 and Day 29.
干预措施: Risankizumab (Drug)
Part 3: PsA Participants-Separate Administration
Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29.
干预措施: Guselkumab (Drug)
Part 3: PsA Participants-Separate Administration
Participants with PsA will receive a single dose of either risankizumab or guselkumab SC on Day 1 and Day 29.
干预措施: Risankizumab (Drug)
结局指标
主要结局
Parts 2 and 3: Synovial Tissue versus Serum Concentration Ratio
时间窗: Up to Week 12
Synovial tissue versus serum concentration ratio will be summarized.
Parts 1 , 2 and 3: Skin Tissue versus Serum Concentration Ratio
时间窗: Up to Week 12
Skin tissue versus serum concentration ratio will be summarized.
Parts 2 and 3: Colon Tissue versus Serum Concentration Ratio
时间窗: Up to Week 4
Colon tissue versus serum concentration ratio will be summarized.
Part 1: Colon Tissue versus Serum Concentration Ratio
时间窗: Up to Week 8
Colon tissue versus serum concentration ratio will be summarized.
次要结局
- Parts 1, 2 and 3: Area Under the Plasma Concentration-time Curve from Time 0 to infinity (AUC[0 - Infinity]) of Guselkumab and Risankizumab(Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24)
- Parts 1, 2 and 3: Terminal Half-life (T1/2)(Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24)
- Parts 1, 2 and 3: Time to Reach Maximum Observed Serum Concentration (Tmax) of Guselkumab and Risankizumab(Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24)
- Parts 1, 2 and 3: Maximum Observed Serum Concentration (Cmax) of Guselkumab and Risankizumab(Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24)
- Parts 1, 2 and 3: Apparent Total Clearance (CL/F) of Guselkumab and Risankizumab(Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24)
- Parts 1, 2 and 3: Apparent Volume of Distribution Based on Terminal Phase (Vz/F) of Guselkumab and Risankizumab(Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24)
- Parts 1, 2 and 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of Guselkumab and Risankizumab(Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24)
- Parts 1, 2 and 3: Number of Participants with Antibodies to Guselkumab and Risankizumab(Part 1: Up to Week 16, Parts 2 and 3: Up to Week 24)