A Study of Ramucirumab (LY3009806) in Healthy Participants

Eli Lilly and Company50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Ramucirumab - IVDRUG

Administered IV.

Placebo - IVDRUG

Administered IV.

Ramucirumab - SCDRUG

Administered SC.

Placebo - SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to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

Locations (1)

Covance Clinical Research Inc

Daytona Beach, Florida, United States

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

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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose

Data from ClinicalTrials.gov

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