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

JRCT ID: jRCT2031210359

Registered date:02/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy Participants
• Date of first enrollment: 11/11/2021
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Part A
Single doses of LY3541860 intravenously (IV) or subcutaneously (SC)
Single doses of Placebo IV or SC

Part B
Multiple doses of LY3541860 IV or SC
Multiple doses of placebo IV or SC

Outcome(s)

Primary Outcome

- 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
-A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
[Time Frame: Baseline through Day 113]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Wakayama Naohiko
• Secondary ID(s): NCT05042310