Status:
COMPLETED
A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess how fast galcanezumab gets into the blood stream and how long it takes the body to remove it. Information about side effects will be collected. The study is open...
Eligibility Criteria
Inclusion
- Participants who are native Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin)
- Participants who are overtly healthy males or females, as determined by medical history and physical examination
Exclusion
- Participants who are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- Participants who have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
- Participants who have received treatment with any CGRP (calcitonin gene related peptide) antibody (including galcanezumab), or antibody against CGRP receptor (including erenumab), or have received biologic agents (such as monoclonal antibodies) within 4 months or 5 half-lives (whichever is longer) prior to dosing
- Participants who have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or non-prescription drugs or food
- women who are lactating
- Participants who show evidence of positive human immunodeficiency virus antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen, or active tuberculosis
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04085289
Start Date
November 20 2019
End Date
May 21 2020
Last Update
June 15 2021
Active Locations (1)
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1
HuaShan Hospital Affiliated To Fudan University
Shanghai, Shanghai Municipality, China, 20040