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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3541860

Study type: Interventional

Funder types: Industry

Identifiers

NCT05042310

18115

J3K-MC-KIAA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 4 patient groups, including a placebo group

LY3541860 (Part A)

Experimental group

Description:

Single doses of LY3541860 administered intravenously (IV) or subcutaneously (SC).

Treatment:

Drug: LY3541860

LY3541860 (Part B)

Experimental group

Description:

Multiple doses of LY3541860 administered either IV or SC.

Treatment:

Drug: LY3541860

Placebo (Part A)

Placebo Comparator group

Description:

Single doses of Placebo administered either IV or SC.

Treatment:

Drug: Placebo

Placebo (Part B)

Placebo Comparator group

Description:

Multiple doses of Placebo administered either IV or SC.

Treatment:

Drug: Placebo