Clinical trial NCT05042310: A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 94
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: 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
timeFrame: Baseline through Day 113
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860
timeFrame: Predose on Day 1 through Day 113
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860
timeFrame: Predose on Day 1 through Day 113
Other outcomes:
Locations:
city: Hachioji
country: Japan
facility: P-One Clinic
state: Tokyo
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: