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A Study of Ramucirumab (LY3009806) in Healthy Participants

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ClinicalTrials.gov Identifier: NCT04495478
Recruitment Status : Active, not recruiting
First Posted : July 31, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Ramucirumab - IV Drug: Placebo - IV Drug: Ramucirumab - SC Drug: Placebo - SC Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : May 9, 2021
Estimated Study Completion Date : May 9, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ramucirumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ramucirumab - Intravenous (IV)
Ramucirumab administered IV.
 Drug: Ramucirumab - IV
Administered IV.
Other Name: LY3009806
Placebo Comparator: Placebo - IV
Placebo administered IV.
 Drug: Placebo - IV
Administered IV.
Experimental: Ramucirumab - Subcutaneous (SC)
Ramucirumab administered SC.
 Drug: Ramucirumab - SC
Administered SC.
Other Name: LY3009806
Placebo Comparator: Placebo - SC
Placebo administered SC.
 Drug: Placebo - SC
Administered SC.


Outcome Measures
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Primary Outcome Measures :
  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 ]
    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  2. 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)

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Ramucirumab [ Time Frame: Baseline through Day 90 ]
    PK: AUC of Ramucirumab

  4. PK: Maximum Concentration (Cmax) of Ramucirumab [ Time Frame: Baseline through Day 90 ]
    PK: Cmax of Ramucirumab


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495478


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04495478    
Other Study ID Numbers: 17748
I4T-MC-JVDT ( Other Identifier: Eli Lilly and Company )
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 15, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ramucirumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs