A Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY4355756 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 123
- 试验地点
- 1
- 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 the study is to assess how LY4355756 is absorbed by the body and how safe it is to healthy participants.
There will be four inpatient stays at the clinical research unit (CRU). For Part A there will be 5 continuous days, Part B 22 continuous days, Part C 5 continuous days in each of the 3 periods, and Part D 18 continuous days in the CRU.
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)
盲法说明
Parts A and B are Double-Blinded, Parts C and D are Open-Label
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, electrocardiogram (ECGs), and vital signs
- •Have a body mass index within the range 18.0-32.0 kilograms per square meter (kg/m²) (inclusive)
- •Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB)
- •Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
排除标准
- •Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders, or abnormal laboratory values at screening
- •Have an abnormality in 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participating in the study or may confound ECG data analysis
- •Have a diagnosis or history of malignancy within 5 years prior to screening
- •Exceptions:
- •basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •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 or presence of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food
- •Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization visit, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment
- •Have a current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
- •Have received any live (including attenuated live vaccines), non-live, or inactivated vaccine(s) within less than 4 weeks before randomization or intend to receive them during the study
- •Are individuals AFAB who, during the study, are pregnant, have positive pregnancy testing, intend to become pregnant, are lactating, or intend to breastfeed
研究组 & 干预措施
LY4355756 Part A
Single-ascending dose (SAD) of LY4355756 administered orally
干预措施: LY4355756 (Drug)
LY4355756 Part B
Multiple-ascending doses (MAD) of LY4355756 administered orally
干预措施: LY4355756 (Drug)
LY4355756 Part C
Single dose of LY4355756 administered orally in each of three study periods
干预措施: LY4355756 (Drug)
LY4355756 + Midazolam Part D
LY4355756 and midazolam co-administered orally
干预措施: LY4355756 (Drug)
LY4355756 + Midazolam Part D
LY4355756 and midazolam co-administered orally
干预措施: Midazolam (Drug)
Midazolam Part D
Midazolam administered orally
干预措施: Midazolam (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 the Safety Follow up Visit (6 months)
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to the Safety Follow up Visit (6 months)
次要结局
- PK: AUC of Midazolam(Baseline up to Day 14)
- PK: Cmax of Midazolam(Baseline up to Day 14)
- Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4355756(Baseline up to Day 18)
- PK: Maximum Plasma Concentration (Cmax) of LY4355756(Baseline up to Day 18)