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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3541860; Drug: Placebo

• Registration Number: NCT05042310
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-13
• Study Start: 2021-11-11
• Primary Completion: 2023-12-27
• Study Completion: 2023-12-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3541860 (Part A)	LY3541860	Single doses of LY3541860 administered intravenously (IV) or subcutaneously (SC).
Placebo (Part A)	Placebo	Single doses of Placebo administered either IV or SC.
Placebo (Part B)	Placebo	Multiple doses of Placebo administered either IV or SC.
LY3541860 (Part B)	LY3541860	Multiple doses of LY3541860 administered either IV or SC.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860	Predose on Day 1 through Day 113	PK: AUC of LY3541860
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860	Predose on Day 1 through Day 113	PK: Cmax of LY3541860

Trial Locations

Locations (1)

P-One Clinic; 🇯🇵 Hachioji, Tokyo, Japan