Phase 1
Completed N=30
A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants
Healthy
Source: ClinicalTrials.gov NCT04085289 ↗
Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Jun 2021
Primary outcomePrimary: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab — 12.6; 27.2 micrograms per milliliter (μg/mL)
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 to healthy Chinese participants. It will last up to about 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab |
12.6; 27.2 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab |
558; 1190 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04085289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.