A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3872386 in Healthy Participants, a Multiple-Ascending Dose Study of LY3872386 in Patients With Atopic Dermatitis, and an Open-Label Multiple-Dose Evaluation of the Safety and Tolerability of Prednisone in Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Part A: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs) and Other Non-serious Adverse Events (AEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of LY3872386 in healthy participants and participants with atopic dermatitis. The safety of prednisone is also evaluated in healthy participants. Blood tests will be performed to investigate how the body processes the LY3872386 following single and multiple dosing in healthy participants and participants with atopic dermatitis. Blood tests will also be performed to investigate how the body processes the prednisone in healthy participants. The study is conducted in three parts (part A, B and C). The study will last up to approximately 85, 183 and 44 days for parts A, B, and C, respectively.
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
Part A, B are double blind and part C is 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
- •Part A and C:
- •Overtly healthy as determined by medical evaluation
- •To qualify as Japanese for the purpose of this study, the participant must be first generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan
- •To qualify as Chinese for the purpose of this study, the participant must be, at a minimum, third-generation Chinese, defined as all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
- •Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
- •Male participants who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in part A and C
- •Participants who have a diagnosis of atopic dermatitis at least 12 months prior to screening as defined by the American Academy of Dermatology
- •Have a history, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or participants who failed systemic therapies intended to treat atopic dermatitis or a history of intolerance to topical therapy
- •Have a body mass index of 18.0 to 38.0 kilograms per square meter (kg/m²), inclusive
- •Male participants who agree to use highly effective or effective methods of contraception, women not of childbearing potential and women of childbearing potential may participate in part B
排除标准
- •Women who are pregnant and/or lactating
- •Participants who have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette- Guérin within 35 days of screening
- •Have a history or presence of multiple or severe allergies or an anaphylactic reaction to prescription or nonprescription drugs
- •Have a known history of diabetes
- •Have fasting glucose level of ≥126 milligrams per deciliter (mg/dL) and glycated hemoglobin ≥6.5 percent (%) and/or taking anti-diabetes medications at screening
- •Have known history of osteoporosis
研究组 & 干预措施
Part A: LY3872386
Single doses of LY3872386 (low dose, mid dose, and high dose) administered intravenously (IV) in healthy participants.
干预措施: LY3872386 (Drug)
Part B: LY3872386
Part B was planned but not initiated as study terminated early due to emerging nonclinical data.
干预措施: LY3872386 (Drug)
Part C: Prednisone
Part C was planned but not initiated as study terminated early due to emerging nonclinical data.
干预措施: Prednisone (Drug)
Placebo
Placebo administered IV in healthy participants.
干预措施: Placebo (Drug)
结局指标
主要结局
Part A: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs) and Other Non-serious Adverse Events (AEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 85
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.
Part B: Number of Participants With One or More TEAEs, SAEs and Other Non-serious AEs Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 183
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug. Zero participants were analyzed in this outcome as study was terminated early.
Part C: Number of Participants With One or More TEAEs, SAEs and Other Non-serious AEs Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Day 44
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug. Zero participants were analyzed in this outcome as study was terminated early.
次要结局
- Pharmacokinetics (PK): Part A and B: Maximum Observed Concentration (Cmax) of LY3872386(Day 1: predose, end of infusion, 3 hours, 6 hours, and 12 hours postdose, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose (Part A))
- PK: Part A and B: Area Under the Concentration Versus Time Curve (AUC) of LY3872386(Day 1: predose, end of infusion, 3 hours, 6 hours, and 12 hours postdose, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose (Part A))
- PK: Part C: Cmax of Prednisone and Prednisolone(Predose up to 12 hours post dose on day 14 and day 30)
- PK: Part C: AUC of Prednisone and Prednisolone(Predose up to 12 hours post dose on day 14 and day 30)