A Phase 1, Multicenter, Randomized, Placebo-Controlled, Investigator- and Participant-Blinded, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4213663 in Healthy Participants, and Two Open-Label, Multiple-Dose Evaluations of LY4213663 in Patients With Rheumatoid Arthritis.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 141
- 试验地点
- 20
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with rheumatoid arthritis (RA). The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last approximately 33 weeks excluding screening.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m²), inclusive
- •Part C and D Only:
- •Have a body weight at least 50 kilograms and BMI within the range 18.0 to 40.0 kg/m² (inclusive) at screening
- •Have a diagnosis of adult-onset RA for at least 3 months prior to screening
排除标准
- •Healthy Participants for SAD Part A and MAD Part B Only:
- •Have a history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Participants with RA for Parts C and D Only:
- •Have Class 4 RA according to American College of Rheumatology (ACR) revised criteria
- •Have a 12-lead electrocardiogram (ECG) abnormality at screening
- •Have a current or recent acute active infection
研究组 & 干预措施
LY4213663 (Part B)
Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants
干预措施: LY4213663 (Drug)
Placebo (Part B)
MAD placebo administered SC and IV
干预措施: Placebo (Drug)
Placebo (Part A)
SAD placebo administered SC and IV
干预措施: Placebo (Drug)
LY4213663 (Parts C and D)
Multiple doses of LY4213663 administered SC and IV in participants with RA
干预措施: LY4213663 (Drug)
LY4213663 (Part A)
Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants
干预措施: LY4213663 (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Week 33
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4213663(Baseline up to Week 33)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY4213663(Baseline up to Week 33)