A Study of Galcanezumab in Healthy Participants.

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02836613

16203

I5Q-MC-CGAQ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating galcanezumab, and have previously received galcanezumab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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Galcanezumab Reference

Active Comparator group

Description:

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

Treatment:

Biological: Galcanezumab

Galcanezumab Test

Experimental group

Description:

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

Treatment:

Biological: Galcanezumab