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A Study of LY3461767 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04352114
Recruitment Status : Completed
First Posted : April 20, 2020
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3461767 - SC Drug: LY3461767 - IV Drug: Placebo - SC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants
Actual Study Start Date : June 15, 2020
Actual Primary Completion Date : January 13, 2021
Actual Study Completion Date : January 13, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3461767 - Subcutaneous (SC)
LY3461767 administered SC.
 Drug: LY3461767 - SC
Administered SC.
Placebo Comparator: Placebo - SC
Placebo administered SC.
 Drug: Placebo - SC
Administered SC.
Experimental: LY3461767 - Intravenous (IV)
LY3461767 administered IV.
 Drug: LY3461767 - IV
Administered IV.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Day 29 ]
    A summary of 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 Observed Drug Concentration (Cmax) of LY3461767 [ Time Frame: Baseline through Day 29 ]
    PK: Cmax of LY3461767

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767 [ Time Frame: Baseline through Day 29 ]
    PK: AUC of LY3461767


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352114


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
United States, Texas
Covance Dallas
Dallas, Texas, United States, 75247
Singapore
Lilly Nus Centre for Clin Pharmacology
Singapore, Singapore, 138623
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04352114    
Other Study ID Numbers: 17517
J2L-MC-EZBA ( Other Identifier: Eli Lilly and Company )
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No