A Study of Ramucirumab (LY3009806) in Healthy Participants

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 9, 2021

Interventions

  • Drug: Ramucirumab – IV
    • Administered IV.
  • Drug: Placebo – IV
    • Administered IV.
  • Drug: Ramucirumab – SC
    • Administered SC.
  • Drug: Placebo – SC
    • Administered SC.

Arms, Groups and Cohorts

  • Experimental: Ramucirumab – Intravenous (IV)
    • Ramucirumab administered IV.
  • Placebo Comparator: Placebo – IV
    • Placebo administered IV.
  • Experimental: Ramucirumab – Subcutaneous (SC)
    • Ramucirumab administered SC.
  • Placebo Comparator: Placebo – SC
    • Placebo administered SC.

Clinical Trial Outcome Measures

Primary Measures

  • 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 through Day 90
    • A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
  • Percentage of Participants with an Injection Site Reaction (ISR[s])
    • Time Frame: Day 1 Predose through Day 90
    • Percentage of Participants with an ISR(s)
  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Ramucirumab
    • Time Frame: Baseline through Day 90
    • PK: AUC of Ramucirumab
  • PK: Maximum Concentration (Cmax) of Ramucirumab
    • Time Frame: Baseline through Day 90
    • PK: Cmax of Ramucirumab

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST), Study Director, Eli Lilly and Company
  • Overall Contact(s)
    • This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, ClinicalTrials.gov@lilly.com

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