NCT04352114

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2020

Typical duration for phase_1 healthy

Geographic Reach
2 countries

3 active sites

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

April 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

April 16, 2020

Last Update Submit

February 4, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767

    Baseline through Day 29

  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767

    Baseline through Day 29

Study Arms (3)

LY3461767 - Subcutaneous (SC)

EXPERIMENTAL

LY3461767 administered SC.

Drug: LY3461767 - SC

Placebo - SC

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo - SC

LY3461767 - Intravenous (IV)

EXPERIMENTAL

LY3461767 administered IV.

Drug: LY3461767 - IV

Interventions

LY3461767 - SCDRUG

Administered SC.

LY3461767 - Subcutaneous (SC)
LY3461767 - IVDRUG

Administered IV.

LY3461767 - Intravenous (IV)
Placebo - SCDRUG

Administered SC.

Placebo - SC

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

Lilly Nus Centre for Clin Pharmacology

Singapore, 138623, Singapore

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
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 20, 2020

Study Start

June 15, 2020

Primary Completion

January 13, 2021

Study Completion

January 13, 2021

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)SG(1)