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A Safety Study of LY3462817 in Healthy Participants

NCT ID: NCT03715192

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-13

Study Completion Date

2019-12-11

Brief Summary

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This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to healthy participants. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including screening.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3462817 - IV

Escalating doses of LY3462817 administered as a single intravenous (IV) infusion in healthy participants

Group Type EXPERIMENTAL

LY3462817 IV

Intervention Type BIOLOGICAL

Administered IV

Placebo

Normal saline administered as a single IV infusion in healthy participants

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

LY3462817 - SC

Single dose of LY3462817 administered as subcutaneous (SC) injections in healthy participants

Group Type EXPERIMENTAL

LY3462817 SC

Intervention Type BIOLOGICAL

Administered SC

Interventions

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LY3462817 IV

Administered IV

Intervention Type BIOLOGICAL

LY3462817 SC

Administered SC

Intervention Type BIOLOGICAL

Placebo

Administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Weight at least 45 kilograms (kg)

Exclusion Criteria

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have cancer or a malignant disease in the past 5 years
* 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
* Are unwilling to receive study drug administration by injections or through the veins
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Lilly Nus Centre for Clin Pharmacology

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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J1A-MC-KDAB

Identifier Type: OTHER

Identifier Source: secondary_id

17089

Identifier Type: -

Identifier Source: org_study_id