NCT05042310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2021

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 11, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2.1 years

First QC Date

September 8, 2021

Last Update Submit

April 4, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860

    Predose on Day 1 through Day 113

  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860

    Predose on Day 1 through Day 113

Study Arms (4)

LY3541860 (Part A)

EXPERIMENTAL

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

Drug: LY3541860

LY3541860 (Part B)

EXPERIMENTAL

Multiple doses of LY3541860 administered either IV or SC.

Drug: LY3541860

Placebo (Part A)

PLACEBO COMPARATOR

Single doses of Placebo administered either IV or SC.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Multiple doses of Placebo administered either IV or SC.

Drug: Placebo

Interventions

LY3541860DRUG

Administered either IV or SC.

LY3541860 (Part A)LY3541860 (Part B)
PlaceboDRUG

Administered either IV or SC.

Placebo (Part A)Placebo (Part B)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

P-One Clinic

Hachiōji, Tokyo, 192-0071, Japan

Location

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 13, 2021

Study Start

November 11, 2021

Primary Completion

December 27, 2023

Study Completion

December 27, 2023

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)