A Study of LY3025876 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01528124
First received: February 3, 2012
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and 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.


Condition Intervention Phase
Healthy Volunteers
Drug: LY3025876
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 LY3025876 in Healthy Subjects

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with one or more drug related Adverse Events or any Serious Adverse Events [ Time Frame: Baseline up to 28 days after administration of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics : Area under the concentration curve (AUC) of LY3025876 [ Time Frame: Up to 48 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics : Maximum concentration (Cmax) of LY3025876 [ Time Frame: Up to 48 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Number of Participants developing anti-LY3025876 antibodies [ Time Frame: Up to 28 days after administration of study drug ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 63
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
0.9% sodium chloride given as a single subcutaneous (SC) injection
Drug: Placebo
Given as a SC injection
Experimental: LY3025876
Single escalating doses of LY3025876 given as SC injections
Drug: LY3025876
Given as a SC injection

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be either a healthy male or a healthy female who cannot become pregnant
  • Have a body mass index (BMI) of 18.5 to 40.0 kg/m^2, inclusive, at screening

Exclusion Criteria:

  • Are allergic to LY3025876 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. Corticosteroids are mainly used to control inflammation.
  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: NCT01528124

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: NCT01528124     History of Changes
Other Study ID Numbers: 14346, I6D-FW-SMRA
Study First Received: February 3, 2012
Last Updated: May 21, 2012
Health Authority: Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on October 22, 2014