A Study of LY3025876 in Healthy Volunteers
- Registration Number
- NCT01528124
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3025876 LY3025876 Single escalating doses of LY3025876 given as subcutaneous injections Placebo Placebo 0.9% sodium chloride given as a single subcutaneous injection
- Primary Outcome Measures
Name Time Method Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events Baseline up to 28 days post-dose 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.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876 Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose Number of Participants Developing Anti-LY3025876 Antibodies Day 28 post-dose Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876.
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876 Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose Area under the concentration-versus-time curve from time zero to infinity \[AUC(0-β)\] of LY3025876.
Trial Locations
- Locations (1)
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.
πΈπ¬Singapore, Singapore