A Study of LY3025876 in Healthy Volunteers

NCT ID: NCT01528124

Last Updated: 2018-07-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-05-31

Brief Summary

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This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

Detailed Description

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Conditions

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Healthy Volunteers

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

0.9% sodium chloride given as a single subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Given as a subcutaneous injection

LY3025876

Single escalating doses of LY3025876 given as subcutaneous injections

Group Type EXPERIMENTAL

LY3025876

Intervention Type DRUG

Given as a subcutaneous injection

Interventions

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LY3025876

Given as a subcutaneous injection

Intervention Type DRUG

Placebo

Given as a subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be either a healthy male or a healthy female who cannot become pregnant
* Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m\^2), inclusive, at screening

Exclusion Criteria

* Are allergic to LY3025876 or related compounds
* Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication
* Have a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids. Corticosteroids are mainly used to control inflammation.
Minimum Eligible Age

21 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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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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I6D-FW-SMRA

Identifier Type: OTHER

Identifier Source: secondary_id

14346

Identifier Type: -

Identifier Source: org_study_id

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