A Study of Ramucirumab (LY3009806) in Healthy Participants

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo - IV; Drug: Placebo - SC; Drug: Ramucirumab - IV; Drug: Ramucirumab - SC

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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• Have previously participated or withdrawn from this study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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Placebo - Intravenous (IV); Participants received single dose of placebo administered IV.	Drug: Placebo - IV; Administered IV.
PLACEBO_COMPARATOR: 350 mg Ramucirumab IV; 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; Administered IV.; Other Names: LY3009806
EXPERIMENTAL: Placebo - Subcutaneous (SC); Participants received single dose of placebo administered SC.	Drug: Placebo - SC; Administered SC.
PLACEBO_COMPARATOR: 350 mg Ramucirumab SC (1x2 mL); Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.	Drug: Ramucirumab - SC; Administered SC.; Other Names: LY3009806
EXPERIMENTAL: 350 mg Ramucirumab SC (2x2 mL); Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.	Drug: Ramucirumab - SC; Administered SC.; Other Names: LY3009806
EXPERIMENTAL: 350 mg Ramucirumab SC (2x1 mL); Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.	Drug: Ramucirumab - SC; Administered SC.; Other Names: LY3009806
EXPERIMENTAL: 700 mg Ramucirumab SC (2x2 mL); Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.	Drug: Ramucirumab - SC; Administered SC.; Other Names: LY3009806

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2020
• Primary Completion (ACTUAL): May 9, 2021
• Study Completion (ACTUAL): May 9, 2021

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (ACTUAL): July 31, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Ramucirumab; Antibodies, Monoclonal
• Other Study ID Numbers: 17748; I4T-MC-JVDT (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No