A Study of LY3025876 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3025876 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528124
• Other study ID #: 14346
• Secondary ID: I6D-FW-SMRA
• Status: Completed
• Phase: Phase 1
• Start date: February 2012
• Est. completion date: May 2012

Study information

• Verified date: September 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Must be either a healthy male or a healthy female who cannot become pregnant

• Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m^2), inclusive, at screening

Exclusion Criteria:

• Are allergic to LY3025876 or related compounds

• Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication

• Have a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids. Corticosteroids are mainly used to control inflammation.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY3025876
Given as a subcutaneous injection
• Placebo
Given as a subcutaneous injection

Locations

Country	Name	City	State
Singapore	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events	Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.	Baseline up to 28 days post-dose
Secondary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876	Area under the concentration-versus-time curve from time zero to infinity [AUC(0-8)] of LY3025876.	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876		Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Secondary	Number of Participants Developing Anti-LY3025876 Antibodies	Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876.	Day 28 post-dose