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A Study of LY3053102 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01736241
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY3053102 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Randomized
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3053102
Single escalating dose (2 mg up to 400 mg) of LY3053102 administered subcutaneously (SQ).
 Drug: LY3053102
Administered SQ
Placebo Comparator: Placebo
Single dose of placebo matching LY3053102 administered SQ.
 Drug: Placebo
Administered SQ


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with One or More Adverse Events (AEs) or Any Serious AEs [ Time Frame: Pre-dose up to Day 31 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3053102 [ Time Frame: Pre-dose up to Day 31 ]
  2. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3053102 [ Time Frame: Pre-dose up to Day 31 ]
  3. Number of Participants Developing Anti-LY3053102 Antibodies [ Time Frame: Pre-dose up to Day 31 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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, Singapore, 117597
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01736241     History of Changes
Other Study ID Numbers: 14514
I6I-MC-LMRA ( Other Identifier: Eli Lilly and Company )
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013