A Study of LY3053102 in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT01736241|
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : July 19, 2018
Last Update Posted : July 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: LY3053102 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, 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|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level.
Placebo Comparator: Placebo
A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks.
- Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs [ Time Frame: Baseline through Day 31 ]A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 [ Time Frame: Time 0 to 168 hours after study drug administration on Day 1 ]AUC curve from time 0 to 168 hours postdose of LY3053102.
- PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 [ Time Frame: Time 0 to 168 hours after study drug administration on Day 1 ]Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.
- Number of Participants Who Developed Anti-LY3053102 Antibodies [ Time Frame: Baseline, up to Day 31 ]LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|