A Study of LY3461767 in Healthy Participants

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants

The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3461767 - SC; Drug: Placebo - SC; Drug: LY3461767 - IV

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Nus Centre for Clin Pharmacology
• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are healthy males, or females of non-child-bearing potential
• Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
• Have clinical laboratory tests within normal ranges as judged by investigator
• Have pulse rate and blood pressure within normal ranges as judged by investigator

Exclusion Criteria:

• Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
• Regularly use known drugs of abuse
• Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
• Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study
• Smoke more than 10 cigarettes per day
• Are current or former smokers with 30-pack-year smoking history
• Have a diagnosis or history of any malignancy
• Have not had appropriate cancer screening, in accordance with country specific guidance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo - SC; Placebo administered SC.	Drug: Placebo - SC; Administered SC.
Experimental: LY3461767 - Subcutaneous (SC); LY3461767 administered SC.	Drug: LY3461767 - SC; Administered SC.
Experimental: LY3461767 - Intravenous (IV); LY3461767 administered IV.	Drug: LY3461767 - IV; Administered IV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767	PK: Cmax of LY3461767	Baseline through Day 29
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767	PK: AUC of LY3461767	Baseline through Day 29

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): January 13, 2021
• Study Completion (Actual): January 13, 2021

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 17517; J2L-MC-EZBA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No