A Study of Galcanezumab in Healthy Participants.

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-11-09

Brief Summary

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The main purpose of this study is to evaluate how much galcanezumab gets into the body after it is given as an injection just under the skin by two different devices. This study will measure how much galcanezumab reaches the blood stream and will test how it affects calcitonin-gene related peptide (CGRP) in blood. Information about any side effects that may occur will be collected. The study will last about 20 weeks for each participant. Screening is required within 45 days prior to the start of the study.

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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

OTHER

Blinding Strategy

NONE

Study Groups

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Galcanezumab Reference

Single dose of 240 milligrams (mg) galcanezumab (LY2951742) administered subcutaneously (SC) by manual prefilled syringe (PFS).

Group Type ACTIVE_COMPARATOR

Galcanezumab

Intervention Type BIOLOGICAL

Administered SC

Galcanezumab Test

Single dose of 240 mg galcanezumab (LY2951742) administered SC by autoinjector.

Group Type EXPERIMENTAL

Galcanezumab

Intervention Type BIOLOGICAL

Administered SC

Interventions

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Galcanezumab

Administered SC

Intervention Type BIOLOGICAL

Other Intervention Names

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LY2951742

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy as determined by medical history and physical examination
* Have a body mass index (BMI) between 19.0 and 35.0 kilogram per meter square (kg/m²)
* Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria

* Have previously completed or withdrawn from this study or any other study investigating galcanezumab, and have previously received galcanezumab
* Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
* Intend to use over-the-counter or prescription medication within 7 days prior to dosing and during the study (especially systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, drugs with known hepatic toxicity, etc). Stable doses of hormone replacement therapy (HRT) are allowed for inclusion at the discretion of the investigator
* Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes