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OpenTrials
Completed

NCT Number: NCT04495478

A Study of Ramucirumab (LY3009806) in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

Ramucirumab - IV

Drug

Administered IV.

Other names: LY3009806

Placebo - IV

Drug

Administered IV.

Ramucirumab - SC

Drug

Administered SC.

Other names: LY3009806

Placebo - SC

Drug

Administered SC.

Primary outcomes

  1. 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

    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

  2. Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug

    Time frame: Day 1 Predose through Day 90

    Number of participants showing ISRs when the drug was administered subcutaneously were reported.

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab

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

    PK: AUC[0-∞] of Ramucirumab.

  4. PK: Maximum Concentration (Cmax) of Ramucirumab

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

    PK: Cmax of Ramucirumab

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2020
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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