A Study of Ramucirumab (LY3009806) in Healthy Participants
NCT ID: NCT04495478
Last Updated: 2023-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2020-07-30
2021-05-09
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo - Intravenous (IV)
Participants received single dose of placebo administered IV.
Placebo - IV
Administered IV.
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.
Ramucirumab - IV
Administered IV.
Placebo - Subcutaneous (SC)
Participants received single dose of placebo administered SC.
Placebo - SC
Administered SC.
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.
Ramucirumab - SC
Administered SC.
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.
Ramucirumab - SC
Administered SC.
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.
Ramucirumab - SC
Administered SC.
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.
Ramucirumab - SC
Administered SC.
Interventions
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Ramucirumab - IV
Administered IV.
Placebo - IV
Administered IV.
Ramucirumab - SC
Administered SC.
Placebo - SC
Administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Covance Clinical Research Inc
Daytona Beach, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I4T-MC-JVDT
Identifier Type: OTHER
Identifier Source: secondary_id
17748
Identifier Type: -
Identifier Source: org_study_id
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