A Phase 1, Randomized, Placebo-controlled, Investigator and Participant Blinded, Single-ascending Dose and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4005130 in Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and 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 LY4005130 is tolerated and what side effects may occur in healthy participants. 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 check how much LY4005130 gets into the bloodstream and how long it takes the body to eliminate it.
Part A for the single-ascending doses (SAD) of the study will last about 12 weeks with 9 visits. Part B for the multiple-ascending doses (MAD) of the study will either last about 16 weeks with 13 visits or 26 weeks with 14 visits not including 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
- Double (Participant, Investigator)
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
- 是
入选标准
- •Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead (electrocardiogram) ECG. If any values are outside the normal range and considered to be significant, for example, elevated white blood cell count, the respective test may be repeated once at the discretion of the investigator without consultation with the sponsor
- •If enrolled as Japanese or Chinese, the entry requirements are as follows:
- •To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan
- •To qualify as Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
- •Have a body weight 45 kilogram (kg) or greater and body mass index greater than 18 and less than 32 kilogram per square meter (kg/m²)
排除标准
- •Are an individual of childbearing potential (IOCBP)
- •Have known allergies to LY4005130, related compounds, or any components of the formulation
- •Have received a live vaccine within 28 days of screening or intend to do so during the study or within 28 days after the study
- •Non-live or inactivated vaccinations are allowed
- •Bacillus Calmette Guerin vaccine must not have been administered within 12 months before screening
- •Had a surgical procedure within 12 weeks before screening;
- •during the study, or
- •within 28 days after the study
- •Have a history of allergy to medications that could be used to treat infusion reactions, or to the drug excipients
- •Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, significant history of atopy, or a history of severe posttreatment hypersensitivity reactions. These reactions include, but are not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis
- •Have a diagnosis or history of malignant disease within 5 years prior to screening, with the following exceptions
- •Basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
- •Cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to screening
- •Have had breast cancer within the past 10 years
- •Have a history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection that, in the opinion of the sponsor or investigator, poses an unacceptable risk to the participant
- •Have a current or recent acute, active infection
研究组 & 干预措施
LY4005130 Part A (SAD) IV
A single-ascending dose of LY4005130 administered intravenously (IV)
干预措施: LY4005130 (Drug)
LY4005130 Part A (SAD) Optional
A single-ascending dose of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
干预措施: LY4005130 (Drug)
LY4005130 Part B (MAD) IV
Multiple-ascending doses of LY4005130 administered IV
干预措施: LY4005130 (Drug)
LY4005130 Part B (MAD) SC or IV
Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
干预措施: LY4005130 (Drug)
Placebo Part A (SAD) SC
Placebo administered SC
干预措施: Placebo (Drug)
Placebo Part A (SAD) Optional
A single-ascending dose of placebo administered either SC or IV depending on emerging data from earlier cohorts
干预措施: Placebo (Drug)
Placebo Part B (MAD) IV
Placebo administered IV
干预措施: Placebo (Drug)
Placebo Part A (SAD) IV
Placebo administered IV
干预措施: Placebo (Drug)
Placebo Part B (MAD) SC or IV
Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts
干预措施: Placebo (Drug)
Placebo Part B (MAD) Optional
Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts
干预措施: Placebo (Drug)
LY4005130 Part A (SAD) SC
A single-ascending dose of LY4005130 administered subcutaneously (SC)
干预措施: LY4005130 (Drug)
LY4005130 Part B (MAD) Optional
Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
干预措施: LY4005130 (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline to Study Completion (Up to 26 Weeks)
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4005130(Baseline to Study Completion (Up to 26 Weeks))
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY4005130(Baseline to Study Completion (Up to 26 Weeks))