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)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

History of active tuberculosis or presence of active or latent tuberculosis

History or evidence of clinically significant opportunistic infection

History of serious local infection (for example, cellulitis or abscess) or systemic infection within 90 days prior to screening

Have any nonserious but active infections

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY5625573

    Drug

    Administered orally as tablet

  • Midazolam

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally as tablet

Treatment groups

96 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: LY5625573 Part A - Single Dose HealthyExperimental treatment 1 intervention
Group B: Placebo Part A - Single Dose HealthyPlacebo comparator 1 intervention
Group C: LY5625573 + Midazolam Part B - Multiple Dose HealthyExperimental treatment 2 interventions
Group D: Placebo + Midazolam Part B - Multiple Dose HealthyPlacebo comparator 2 interventions
Group E: LY5625573 Part C - Multiple Dose Elevated hsCRPExperimental treatment 1 intervention
Group F: Placebo Part C - Multiple Dose Elevated hsCRPPlacebo comparator 1 intervention
Group G: LY5625573 Part D - Healthy JapaneseExperimental treatment 1 intervention
Group H: Placebo Part D - Healthy JapanesePlacebo comparator 1 intervention
Group I: LY5625573 Part E - Healthy ChineseExperimental treatment 1 intervention
Group J: Placebo Part E - 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

Time frame
Baseline up to Follow up (Days 12 and 24)
2

Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame
Baseline up to Follow up (Days 12 and 24)

Secondary outcomes

1

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY5625573

Time frame
Baseline up to End of Treatment (Day 17)

Other outcomes

Sponsors and contacts

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