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A Study of LY3053102 in Healthy Participants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736241
First Posted: November 29, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
November 26, 2012
November 29, 2012
October 12, 2017
December 2012
July 2013   (Final data collection date for primary outcome measure)
Number of Participants with One or More Adverse Events (AEs) or Any Serious AEs [ Time Frame: Pre-dose up to Day 31 ]
Same as current
Complete list of historical versions of study NCT01736241 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3053102 [ Time Frame: Pre-dose up to Day 31 ]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3053102 [ Time Frame: Pre-dose up to Day 31 ]
  • Number of Participants Developing Anti-LY3053102 Antibodies [ Time Frame: Pre-dose up to Day 31 ]
Same as current
Not Provided
Not Provided
 
A Study of LY3053102 in Healthy Participants
A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3053102 in Healthy Subjects
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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: LY3053102
    Administered SQ
  • Drug: Placebo
    Administered SQ
  • Experimental: LY3053102
    Single escalating dose (2 mg up to 400 mg) of LY3053102 administered subcutaneously (SQ).
    Intervention: Drug: LY3053102
  • Placebo Comparator: Placebo
    Single dose of placebo matching LY3053102 administered SQ.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Normal blood pressure
  • Female participants are not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
  • Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

  • Have known allergies to LY3053102 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
  • Heavy smokers (more than 10 cigarettes a day)
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01736241
14514
I6I-MC-LMRA ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP