A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04085289

17057

I5Q-MC-CGAY (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups, including a placebo group

Galcanezumab

Experimental group

Description:

Participants received single subcutaneous (SC) doses of 120 milligram (mg) or 240 mg Galcanezumab.

Treatment:

Drug: Galcanezumab

Placebo

Placebo Comparator group

Description:

Participants received a single SC dose of Placebo.

Treatment:

Drug: Placebo