NCT07801300尚未招募1 期
A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of Orally Administered LY5625575 in Healthy Participants, Including Japanese and Chinese Populations, and in Participants With Elevated C-Reactive Protein
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 204
- 试验地点
- 2
- 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 main purpose of this study is to evaluate the safety and tolerability of LY5625575 in healthy participants (including Japanese and Chinese) and in participants with high levels of a marker for inflammation (C-reactive protein). The study will also measure how much LY5625575 gets into the bloodstream and how long it takes the body to get rid of it.
The study will last seven to nine weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •All Parts:
- •Individuals not of childbearing potential may participate in this trial.
- •Individuals assigned male at birth may participate in this trial.
- •Healthy as defined by
- •the absence of clinically significant illness and surgery within 35 days prior to first dosing, and
- •the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- •-- Have an estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2021, of greater than or equal to (≥)90 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) at screening.
- •Parts B, C, D, and E:
- •-- Have an eGFR, using the CKD-EPI creatinine equation 2021, of ≥60 mL/minute/1.73 m²
- •Parts A, B, D, and E:
- •-- Have a body mass index ≥18.5 and less than (<)32.0 kilograms per square meter (kg/m²)
- •hsCRP ≥2 mg/L and ≤15 mg/L at screening and Day -
- •Have a body mass index ≥18.5 and <40.0 m
- •-- To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participants' biological grandparents must be of exclusive Japanese descent and born in Japan.
- •To qualify as Chinese for the purpose of this study, all the participants' biological grandparents must be of exclusive Chinese descent and born in China.
排除标准
- •All Parts:
- •Individuals of childbearing potential are excluded from the trial
- •Any clinically significant abnormal finding at physical examination at screening and/or Day -
- •Any clinically significant physical findings in the mouth or tongue (for example, difficulty swallowing) that would be likely to interfere with oral administration of study intervention.
- •History of significant allergic reactions (for example, anaphylactic reaction, hypersensitivity, or angioedema) to any medication or known allergic reactions to drugs related to LY5625575, or to any excipient in the formulation.
- •History of active tuberculosis or presence of active or latent tuberculosis.
- •History or evidence of clinically significant opportunistic infection (for example, invasive candidiasis or pneumocystis pneumonia).
- •History of serious local infection (for example, cellulitis or abscess) or systemic infection (for example, septicemia) within 90 days prior to screening.
- •History of nonserious but active infections
- •History of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection.
- •Presence or history of any abnormality or illness, which in the opinion of the investigator may affect absorption, distribution, metabolism, or elimination of the study intervention.
- •Are currently enrolled in a clinical study involving an investigational medicinal product (IMP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Are currently enrolled in or past participation within the 30 days prior to screening, in a clinical study involving a study intervention for which at least 5 half-lives or 30 days (whichever is longer) have not passed.
- •Have a 12-lead echocardiogram (ECG) abnormality that, in the opinion of the investigator,
- •increases the risks associated with participating in the study
- •may confound ECG data analysis
- •Have blood pressure and/or pulse rate constituting a risk when taking the investigational medicinal product, as determined by the investigator.
- •Clinically significant abnormal laboratory test results at screening, or positive serology test results for hepatitis B surface antigen, hepatitis B core total antibody, hepatitis C virus antibody, or human immunodeficiency virus antigen and antibody, or QuantiFERON®-TB test at screening
- •Positive pregnancy test or lactating participants assigned female at birth at screening and/or Day -
- •Positive drug screen, cotinine test, or alcohol test at screening and/or Day -
- •Any screening laboratory evaluation outside the laboratory reference range that is judged by the investigator to be clinically significant, with the exception of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin (TBL) greater than (>)upper limit of normal (ULN) for these laboratory parameters.
- •Presence of fever (body temperature >37.6°C) (for example, a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to first dosing.
- •Use of medications for the timeframes specified below, with the exception of medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the pharmacokinetic (PK) profile of the study intervention or participant safety (for example, topical drug products without significant systemic exposure):
- •depot injection or implant for 90 days prior to dosing
- •biologics for 90 days (or 5 half-lives, whichever is longer) prior to first dosing
- •live attenuated vaccines for 30 days prior to dosing
- •prescription medications or over-the-counter (OTC) medications and natural health products (including herbal remedies such as St. John's wort, homeopathic and traditional medicines, probiotics, food supplements such as amino acids, essential fatty acids, and protein supplements used in sports, with the exception of vitamins and minerals) for 14 days (or 5 half-lives, whichever is longer) prior to dosing (acetaminophen ≤3 grams/day will be permitted), or
- •any vaccine, including coronavirus disease 2019 (COVID-19) vaccine, for 14 days prior to dosing.
- •History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine, crack, opioid derivatives including heroin, and amphetamine derivatives) within 90 days prior to screening.
- •Any use of tobacco and/or nicotine product within 90 days prior to screening.
- •Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.
- •Have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study.
- •Parts B, C, D, and E:
- •Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- •Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 90 days (at screening and/or Day -1) OR
- •Have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 90 days (at screening and/or Day -1). NOTE: Non-suicidal self-injurious behavior is not considered a suicide-related behavior.
- •Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either
研究组 & 干预措施
LY5625575 (Part A) - Single Dose Healthy
Experimental
Single escalating doses of LY5625575 administered orally in healthy participants.
干预措施: LY5625575 (Drug)
Placebo (Part A) - Single Dose Healthy
Placebo Comparator
Single dose of placebo administered orally in healthy participants.
干预措施: Placebo (Drug)
Placebo (Part B) - Multiple Dose Healthy
Placebo Comparator
Two or more doses of placebo administered orally in healthy participants.
干预措施: Placebo (Drug)
LY5625575 (Part B) - Multiple Dose Healthy
Experimental
Two or more doses of LY5625575 administered orally in healthy participants.
干预措施: LY5625575 (Drug)
LY5625575 (Part C) - Multiple Dose Elevated hsCRP
Experimental
Two or more doses of LY5625575 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP).
干预措施: LY5625575 (Drug)
Placebo (Part C) - Multiple Dose Elevated hsCRP
Placebo Comparator
Two or more doses of placebo administered orally in participants with elevated hsCRP.
干预措施: Placebo (Drug)
LY5625575 (Part D) - Multiple Dose Healthy Japanese
Experimental
Two or more doses of LY5625575 administered orally in healthy Japanese participants.
干预措施: LY5625575 (Drug)
Placebo (Part D) - Multiple Dose Healthy Japanese
Placebo Comparator
Two or more doses of placebo administered orally in healthy Japanese participants
干预措施: Placebo (Drug)
LY5625575 (Part E) - Multiple Dose Healthy Chinese
Experimental
Two or more doses of LY5625575 administered orally in healthy Chinese participants.
干预措施: LY5625575 (Drug)
Placebo (Part E) - Multiple Dose Healthy Chinese
Placebo Comparator
Two or more doses of placebo administered orally in healthy Chinese participants.
干预措施: Placebo (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 Day 24
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
次要结局
- Pharmacokinetics (PK): Area under the Concentration Versus Time Curve (AUC) of LY5625575(Day 1 Predose up to Day 17)
研究者
研究点 (2)
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