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A Study of LY3025876 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
Registration Number
NCT01528124
Lead Sponsor
Eli Lilly and Company
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
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 kilograms per meter squared (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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LY3025876LY3025876Single escalating doses of LY3025876 given as subcutaneous injections
PlaceboPlacebo0.9% sodium chloride given as a single subcutaneous injection
Primary Outcome Measures
NameTimeMethod
Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse EventsBaseline up to 28 days post-dose

Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.

Secondary Outcome Measures
NameTimeMethod
Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Number of Participants Developing Anti-LY3025876 AntibodiesDay 28 post-dose

Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876.

Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose

Area under the concentration-versus-time curve from time zero to infinity \[AUC(0-∞)\] of LY3025876.

Trial Locations

Locations (1)

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.

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Singapore, Singapore

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