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

NCT ID: NCT05042310

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2023-12-27

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3541860 (Part A)

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

Group Type: EXPERIMENTAL

LY3541860

Intervention Type: DRUG

Administered either IV or SC.

LY3541860 (Part B)

Multiple doses of LY3541860 administered either IV or SC.

Group Type: EXPERIMENTAL

LY3541860

Intervention Type: DRUG

Administered either IV or SC.

Placebo (Part A)

Single doses of Placebo administered either IV or SC.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered either IV or SC.

Placebo (Part B)

Multiple doses of Placebo administered either IV or SC.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered either IV or SC.

Interventions

LY3541860

Administered either IV or SC.

Intervention Type: DRUG

Placebo

Administered either IV or SC.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

P-One Clinic

Hachiōji, Tokyo, Japan

Countries

Japan

Other Identifiers

J3K-MC-KIAA

Identifier Type: OTHER

Identifier Source: secondary_id

18115

Identifier Type: -

Identifier Source: org_study_id