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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05042310
Collaborator
(none)
84
Enrollment
1
Location
4
Arms
11
Anticipated Duration (Months)
7.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Oct 12, 2022
Anticipated Study Completion Date :
Oct 12, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY3541860 (Part A)

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

Drug: LY3541860
Administered either IV or SC.

Experimental: LY3541860 (Part B)

Multiple doses of LY3541860 administered either IV or SC.

Drug: LY3541860
Administered either IV or SC.

Placebo Comparator: Placebo (Part A)

Single doses of Placebo administered either IV or SC.

Drug: Placebo
Administered either IV or SC.

Placebo Comparator: Placebo (Part B)

Multiple doses of Placebo administered either IV or SC.

Drug: Placebo
Administered either IV or SC.

Outcome Measures

Primary Outcome Measures

  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 [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

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860 [Predose on Day 1 through Day 113]

    PK: Cmax of LY3541860

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860 [Predose on Day 1 through Day 113]

    PK: AUC of LY3541860

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1P-One ClinicHachiojiTokyoJapan192-0071

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05042310
Other Study ID Numbers:
  • 18115
  • J3K-MC-KIAA
First Posted:
Sep 13, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 15, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2021