A Study of Ramucirumab (LY3009806) in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ramucirumab - SC; Drug: Placebo - IV; Drug: Ramucirumab - IV; Drug: Placebo - SC

• Registration Number: NCT04495478
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-30
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-07-31
• Primary Completion: 2021-05-09
• Study Completion: 2021-05-09
• Status Verified: 2022-05
• Results First Submitted: 2022-05-06
• Results First Submitted QC: 2022-05-17
• Last Update Submitted: 2022-05-17
• Results First Posted: 2023-02-14
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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• Have previously participated or withdrawn from this study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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
350 mg Ramucirumab SC (2x1 mL)	Ramucirumab - SC	Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 1 mL injections.
350 mg Ramucirumab SC (1x2 mL)	Ramucirumab - SC	Participants received single 350 mg ramucirumab SC administered at a concentration of 175 mg/mL as one 2 mL injection.
Placebo - Intravenous (IV)	Placebo - IV	Participants received single dose of placebo administered IV.
350 mg Ramucirumab IV	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.
Placebo - Subcutaneous (SC)	Placebo - SC	Participants received single dose of placebo administered SC.
350 mg Ramucirumab SC (2x2 mL)	Ramucirumab - SC	Participants received single 350 mg ramucirumab SC administered at a concentration of 87.5 mg/mL as two 2 mL injections.
700 mg Ramucirumab SC (2x2 mL)	Ramucirumab - SC	Participants received single 700 mg ramucirumab SC administered at a concentration of 175 mg/mL as two 2 mL injections.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab	1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose	PK: AUC\[0-∞\] of Ramucirumab.
PK: Maximum Concentration (Cmax) of Ramucirumab	1, 8, 24, 48, 72, 96, 120, 144, 168, 264, 336, 504 hours post-dose	PK: Cmax of Ramucirumab
Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug	Day 1 Predose through Day 90	Number of participants showing ISRs when the drug was administered subcutaneously were reported.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	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

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States