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
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
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.
Inclusion Criteria:
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
Part A:
-- 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)
Part C:
Part D:
-- 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.
Part E:
Exclusion Criteria:
All Parts:
Individuals of childbearing potential are excluded from the trial
Any clinically significant abnormal finding at physical examination at screening and/or Day -1.
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,
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 -1.
Positive drug screen, cotinine test, or alcohol test at screening and/or Day -1.
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):
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:
LillyTrials@Lilly.com1-317-615-4559
clinical_inquiry_hub@lilly.com
214-647-9375