A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3079514 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- LY3079514
- Conditions
- Healthy Volunteers
- Sponsor
- Eli Lilly and Company
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of study drug, LY3079514. This study will last about 12 weeks for each participant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Overtly healthy participants as determined by medical history and physical examination
- •To qualify as Japanese for the purpose of this study, the Japanese participant must be first-generation Japanese
- •Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m\^2) and have a minimum body weight of 50 kilograms (kg), inclusive at screening
- •Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Exclusion Criteria
- •Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have an abnormal blood pressure that is considered to be clinically significant, as determined by the investigator
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- •Have known or ongoing psychiatric disorders
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Show evidence of hepatitis C and/or positive hepatitis C antibody
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Arms & Interventions
LY3079514
Single dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion
Intervention: LY3079514
Placebo
Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline to Study Completion (Up to 12 Weeks)
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.
Secondary Outcomes
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514(SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85)
- PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514(SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85)