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A Study of LY3375880 in Healthy Participants

NCT ID: NCT03343587

Last Updated: 2018-12-10

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2018-11-16

Brief Summary

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The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.

This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.

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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LY3375880 Single Dose

Single dose of LY3375880 administered IV or SC

Group Type EXPERIMENTAL

LY3375880 IV

Intervention Type DRUG

administered IV

LY3375880 SC

Intervention Type DRUG

administered SC

Placebo Single Dose

Single dose of placebo administered IV or SC

Group Type PLACEBO_COMPARATOR

Placebo IV

Intervention Type DRUG

administered IV

Placebo SC

Intervention Type DRUG

administered SC

LY3375880 Multiple Dose

Multiple doses of LY3375880 administered IV or SC

Group Type EXPERIMENTAL

LY3375880 IV

Intervention Type DRUG

administered IV

LY3375880 SC

Intervention Type DRUG

administered SC

Placebo Multiple Dose

Multiple doses of placebo administered IV or SC

Group Type PLACEBO_COMPARATOR

Placebo IV

Intervention Type DRUG

administered IV

Placebo SC

Intervention Type DRUG

administered SC

Interventions

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LY3375880 IV

administered IV

Intervention Type DRUG

LY3375880 SC

administered SC

Intervention Type DRUG

Placebo IV

administered IV

Intervention Type DRUG

Placebo SC

administered SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Are overtly healthy males or females, as determined by medical history and physical examination
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria

* Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
* Are women who are of childbearing potential or who are lactating
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Parexel Early Phase Unit at Glendale

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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I9N-MC-FCAA

Identifier Type: OTHER

Identifier Source: secondary_id

16833

Identifier Type: -

Identifier Source: org_study_id