A Study of LY3200327 in Healthy Participants

NCT ID: NCT02595736

Last Updated: 2016-09-12

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body.

The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).

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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Placebo (SC)

Single subcutaneous (SC) dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo (SC)

Intervention Type DRUG

Administered SC

LY3200327 (SC)

Single escalating subcutaneous (SC) dose of LY3200327

Group Type EXPERIMENTAL

LY3200327 (SC)

Intervention Type DRUG

Administered SC

LY3200327 (IV)

Single intravenous (IV) dose of LY3200327

Group Type EXPERIMENTAL

LY3200327 (IV)

Intervention Type DRUG

Administered IV

Placebo (IV)

Single intravenous (IV) dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo (IV)

Intervention Type DRUG

Administered IV

Interventions

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Placebo (SC)

Administered SC

Intervention Type DRUG

LY3200327 (SC)

Administered SC

Intervention Type DRUG

LY3200327 (IV)

Administered IV

Intervention Type DRUG

Placebo (IV)

Administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At the time of initial screening, in general good health
* First-generation healthy Japanese (age 20 to 65 years) will be included

Exclusion Criteria

* Pregnancy or breastfeeding during the study
* Chronic infection
* Treatment with prohibited medications
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 International/ California Clinical Trials

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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I8C-MC-GSFA

Identifier Type: OTHER

Identifier Source: secondary_id

15577

Identifier Type: -

Identifier Source: org_study_id

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