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Not Yet Recruiting NCT07867340

A Study of Single and Multiple Doses of LY5625573 in Healthy Participants, Including Japanese and Chinese Populations, and Participants With Inflammation (High C-Reactive Protein)

Conditions: C-Reactive Protein

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 96
Sponsor: Eli Lilly and Company

Location: Collaborative Neuroscience Network - CNS Los Alamitos California

Summary

The purpose of this study is to learn if LY5625573 is safe and how well it is tolerated in healthy participants, including Japanese and Chinese participants, and in participants with high levels of a marker for inflammation (C-reactive protein). The study will also look at how the body absorbs, breaks down, and clears the study drug (pharmacokinetics), how the study drug works in the body, and whether it interacts with certain other medications by affecting how the body processes them. Participation in the study will last up to approximately 7 weeks for Part A and 8.5 weeks for Parts B, C, D, and E. For each participant there will be one stay at the clinical research unit (CRU) lasting 5 nights for Part A, 18 nights for Parts B and C, and 17 nights for Parts D and E.

Eligibility Criteria

Inclusion Criteria: * 21 to 65 years of age, inclusive, at the time of signing the informed consent if enrolled in Singapore * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring * Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator * Have a hemoglobin level of at least 12.5 grams per deciliter (g/dL) for participants assigned male at birth (AMAB) and at least 11.4 g/dL for participants assigned female at birth (AFAB) * Individuals AFAB who are individual not of childbearing potential (INOCBPs) may participate in this trial Parts A, B, D, and E * Have a body mass index (BMI) greater than or equal to (≥)18.5 and less than or equal to (≤) 32.0 kilograms per square meter (kg/m²) * Have an estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2021, of ≥90 milliliter per minute per 1.73 square meters (mL)/minute/1.73 m² at screening Part C * Have a BMI ≥18.5 and \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07867340). StuddyBuddy aggregates publicly available trial information.