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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042310
• Other study ID #: 18115
• Secondary ID: J3K-MC-KIAA
• Status: Completed
• Phase: Phase 1
• Start date: November 11, 2021
• Est. completion date: December 27, 2023

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3541860
Administered either IV or SC.
• Placebo
Administered either IV or SC.

Locations

Country	Name	City	State
Japan	P-One Clinic	Hachioji	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline through Day 113
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860	PK: Cmax of LY3541860	Predose on Day 1 through Day 113
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860	PK: AUC of LY3541860	Predose on Day 1 through Day 113