A Study of Galcanezumab in Healthy Participants.

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02836613

Run by

Eli Lilly and Company

People needed

160

Starts

2016-07-01

Expected to finish

2017-11-09

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Have previously completed or withdrawn from this study or any other study investigating galcanezumab, and have previously received galcanezumab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

Where it is running

• Covance Clinical Research Inc — Daytona Beach, Florida, United States
• Covance Clinical Research Inc — Evansville, Indiana, United States
• Covance — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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