NCT04085289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2019

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 15, 2021

Completed
Last Updated

June 15, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

September 10, 2019

Results QC Date

May 20, 2021

Last Update Submit

May 20, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics: Maximum Concentration (Cmax) 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: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab

    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

Study Arms (2)

Galcanezumab

EXPERIMENTAL

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

Drug: Galcanezumab

Placebo

PLACEBO COMPARATOR

Participants received a single SC dose of Placebo.

Drug: Placebo

Interventions

GalcanezumabDRUG

Administered SC

Also known as: LY2951742
Galcanezumab
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HuaShan Hospital Affiliated To Fudan University

Shanghai, Shanghai Municipality, 20040, China

Location

MeSH Terms

Interventions

galcanezumab

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 11, 2019

Study Start

November 20, 2019

Primary Completion

May 21, 2020

Study Completion

May 21, 2020

Last Updated

June 15, 2021

Results First Posted

June 15, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)