A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants
- Conditions
- Healthy
- Interventions
- Drug: Placebo - SCDrug: LY3493269 - SCDrug: LY3493269 - IV
- Registration Number
- NCT04178733
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Overtly healthy male or a female who cannot get pregnant
- Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/mΒ²), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
- Have veins suitable for ease of blood sampling
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously completed or withdrawn from this study
- Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Have been treated with weight loss medications within 3 months of screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo - SC Placebo - SC Participants received Placebo subcutaneously (SC). 0.15 mg LY3493269 SC LY3493269 - SC Participants received 0.15 mg LY3493269 SC. 1.5 mg LY3493269 SC LY3493269 - SC Participants received 1.5 mg LY3493269 SC. 0.5 mg LY3493269 IV LY3493269 - IV Participants received 0.5 mg LY3493269 intravenously (IV). 0.5 mg LY3493269 SC LY3493269 - SC Participants received 0.5 mg LY3493269 SC.
- Primary Outcome Measures
Name Time Method Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Baseline through final follow-up (Up To Day 43) A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-β) of LY3493269 Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-β) of LY3493269
PK: Maximum Concentration (Cmax) of LY3493269 Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination PK: Maximum Concentration (Cmax) of LY3493269
PK: Time to Maximum Concentration (Tmax) of LY3493269 Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination PK: Time to Maximum Concentration (Tmax) of LY3493269
Trial Locations
- Locations (1)
Lilly Centre for Clinical Pharmacology
πΈπ¬Singapore, Singapore