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A Study of LY3053102 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01736241
First received: November 26, 2012
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: LY3053102
Drug: Placebo
Phase 1

Study Type: Interventional
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 53
Study Start Date: December 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01736241     History of Changes
Other Study ID Numbers: 14514, I6I-MC-LMRA
Study First Received: November 26, 2012
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration
Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on November 25, 2014