A Study of LY3053102 in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study will also 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. The study is expected to last approximately 8 weeks for each participant (up to 4 weeks from the screening visit to the administration of study drug and an additional 4 weeks of follow up).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3053102 in Healthy Subjects|
- Number of Participants with One or More Adverse Events (AEs) or Any Serious AEs [ Time Frame: Pre-dose up to Day 31 ] [ Designated as safety issue: Yes ]
- Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3053102 [ Time Frame: Pre-dose up to Day 31 ] [ Designated as safety issue: No ]
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3053102 [ Time Frame: Pre-dose up to Day 31 ] [ Designated as safety issue: No ]
- Number of Participants Developing Anti-LY3053102 Antibodies [ Time Frame: Pre-dose up to Day 31 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Single escalating dose (2 mg up to 400 mg) of LY3053102 administered subcutaneously (SQ).
Placebo Comparator: Placebo
Single dose of placebo matching LY3053102 administered SQ.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736241
|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, Singapore, 117597|
|Study Director:||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|