Safety Study of LY3041658 in Healthy Participants

NCT ID: NCT02148627

Last Updated: 2017-02-15

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-16

Study Completion Date

2017-02-11

Brief Summary

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The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months.

Protocol amended in January, 2016 to include first generation Japanese participants.

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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LY3041658 (IV)

Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.

Group Type EXPERIMENTAL

LY3041658 (IV)

Intervention Type DRUG

Administered as slow IV infusion

LY3041658 (SC)

Single dose of LY3041658 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3041658 (SC)

Intervention Type DRUG

Administered SC

Placebo

Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as slow IV infusion

Interventions

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LY3041658 (SC)

Administered SC

Intervention Type DRUG

LY3041658 (IV)

Administered as slow IV infusion

Intervention Type DRUG

Placebo

Administered as slow IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All:

* Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²).
* Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10\^3/microliter (uL), inclusive.
* First-generation Japanese:

* Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan.
* Are 20 to 65 years of age, inclusive, at the time of initial screening.

Exclusion Criteria

\- Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.
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

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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I7P-MC-DSAA

Identifier Type: OTHER

Identifier Source: secondary_id

15164

Identifier Type: -

Identifier Source: org_study_id

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