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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
Results First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 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

Arm Intervention/treatment
Experimental: LY3053102
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.
Drug: LY3053102
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.
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Had known allergies to LY3053102 or related compounds
  • Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
  • Had 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)

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

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
Results First Posted: July 19, 2018
Last Update Posted: July 19, 2018
Last Verified: September 2017