A Study of Ramucirumab (LY3009806) in Healthy Participants

Study Overview
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Brief Summary
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This study evaluates a new formulation of ramucirumab, a drug approved for several types of cancer. In this study of healthy participants, a small amount of ramucirumab will be given by injection either into a vein or just under the skin. Study doctors will measure the amount of ramucirumab in the bloodstream. Side effects and tolerability will be documented. The study will last for about 16 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Official Title
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A Single-Dose Study in Healthy Participants to Characterize Ramucirumab Pharmacokinetics and Investigate Injection Site Reactions Following an Intravenous Infusion or Subcutaneous Administration of Ramucirumab

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ramucirumab - IV
* Drug: Placebo - IV
* Drug: Ramucirumab - SC
* Drug: Placebo - SC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) Have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m ²), inclusive Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study Exclusion Criteria: 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30 days or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to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 Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo - Intravenous (IV)<br>Participants received single dose of placebo administered IV. | Drug: Placebo - IV<br>* Administered IV.<br>|
| Placebo Comparator: 350 mg Ramucirumab IV<br>Participants received single 350 milligram (mg) ramucirumab administered as a 60-minute intravenous infusion at a concentration of 10 milligram per millilitre (mg/mL) as one 35 mL infusion. | Drug: Ramucirumab - IV<br>* Administered IV.<br>* Other names: LY3009806;|
| Experimental: Placebo - Subcutaneous (SC)<br>Participants received single dose of placebo administered SC. | Drug: Placebo - SC<br>* Administered SC.<br>|
| Placebo Comparator: 350 mg Ramucirumab SC (1x2 mL)<br>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection. | Drug: Ramucirumab - SC<br>* Administered SC.<br>* Other names: LY3009806;|
| Experimental: 350 mg Ramucirumab SC (2x2 mL)<br>Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections. | Drug: Ramucirumab - SC<br>* Administered SC.<br>* Other names: LY3009806;|
| Experimental: 350 mg Ramucirumab SC (2x1 mL)<br>Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections. | Drug: Ramucirumab - SC<br>* Administered SC.<br>* Other names: LY3009806;|
| Experimental: 700 mg Ramucirumab SC (2x2 mL)<br>Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections. | Drug: Ramucirumab - SC<br>* Administered SC.<br>* Other names: LY3009806;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, risk of death), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 90 | 
| Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug | Number of participants showing ISRs when the drug was administered subcutaneously were reported. | Day 1 Predose through Day 90 | 
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab | PK: AUC[0-∞] of Ramucirumab. | 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose | 
| PK: Maximum Concentration (Cmax) of Ramucirumab | PK: Cmax of Ramucirumab | 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose |