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Completed

NCT Number: NCT05042310

A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3541860 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3541860 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 113 days.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

P-One Clinic

Hachiōji, Tokyo, 192-0071, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are male or female not of childbearing potential
  • Have a body weight between 18 and 32 kilograms per square meter (kg/m²) and a body weight ≥ 50 kilograms (kg)
  • Have veins suitable for blood sampling

Exclusion criteria

  • Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
  • Have active or latent TB
  • Have had breast cancer within the past 10 years or had lymphoma, leukemia, or any malignancy within the past 5 years
  • Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
  • Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
  • Have previously completed a clinical trial investigating any other molecule targeting CD19, CD20 or have previously discontinued from this study after receiving LY3541860
  • Are currently participating in or completed a clinical trial within the last 30 days
  • Have received a vaccine containing a live (attenuated) virus within 28 days of screening or intend to receive during the course of the study.

Treatment and study plan

LY3541860

Drug

Administered either IV or SC.

Placebo

Drug

Administered either IV or SC.

Primary outcomes

  1. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline through Day 113

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

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860

    Time frame: Predose on Day 1 through Day 113

    PK: Cmax of LY3541860

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860

    Time frame: Predose on Day 1 through Day 113

    PK: AUC of LY3541860

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Randomized, Participant- and Investigator-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3541860 in Healthy Japanese and Non-Japanese Participants

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2021
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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