A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Galcanezumab

• Registration Number: NCT04085289
• Lead Sponsor: Eli Lilly and Company

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 to healthy Chinese participants. It will last up to about 24 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-11
• Study Start: 2019-11-20
• Primary Completion: 2020-05-21
• Study Completion: 2020-05-21
• Status Verified: 2021-05
• Results First Submitted: 2021-05-20
• Results First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Results First Posted: 2021-06-15
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received a single SC dose of Placebo.
Galcanezumab	Galcanezumab	Participants received single subcutaneous (SC) doses of 120 milligram (mg) or 240 mg Galcanezumab.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab	8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-∞\]) of Galcanezumab.
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab	8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose	Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.

Trial Locations

Locations (1)

HuaShan Hospital Affiliated To Fudan University; 🇨🇳 Shanghai, Shanghai, China