A Study of LY3053102 in Healthy Participants
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01736241 |
Recruitment Status
:
Completed
First Posted
: November 29, 2012
Last Update Posted
: July 16, 2013
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: LY3053102 Drug: Placebo | Phase 1 |
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 |
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
|
- Number of Participants with One or More Adverse Events (AEs) or Any Serious AEs [ Time Frame: Pre-dose up to Day 31 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

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
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 |
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 |
Last Update Posted: | July 16, 2013 |
Last Verified: | July 2013 |