Health TrialsbyHealthPanel

A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein)

ConditionsHealthy VolunteersC-Reactive Protein
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • LY5625575

    Drug

    Administered orally.

  • Placebo

    Drug

    Administered orally.

Treatment groups

204 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: LY5625575 (Part A) - Single Dose HealthyExperimental treatment 1 intervention
Group B: Placebo (Part A) - Single Dose HealthyPlacebo comparator 1 intervention
Group C: LY5625575 (Part B) - Multiple Dose HealthyExperimental treatment 1 intervention
Group D: Placebo (Part B) - Multiple Dose HealthyPlacebo comparator 1 intervention
Group E: LY5625575 (Part C) - Multiple Dose Elevated hsCRPExperimental treatment 1 intervention
Group F: Placebo (Part C) - Multiple Dose Elevated hsCRPPlacebo comparator 1 intervention
Group G: LY5625575 (Part D) - Multiple Dose Healthy JapaneseExperimental treatment 1 intervention
Group H: Placebo (Part D) - Multiple Dose Healthy JapanesePlacebo comparator 1 intervention
Group I: LY5625575 (Part E) - Multiple Dose Healthy ChineseExperimental treatment 1 intervention
Group J: Placebo (Part E) - Multiple Dose Healthy ChinesePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

Time frame
Baseline up to Day 24

Secondary outcomes

1

Pharmacokinetics (PK): Area under the Concentration Versus Time Curve (AUC) of LY5625575

Time frame
Day 1 Predose up to Day 17

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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