CompletedPhase 1

A Study of Ramucirumab (LY3009806) in Healthy Participants

United States50 participantsStarted 2020-07-30

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to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

What they're measuring

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Timeframe: Baseline through Day 90

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

Timeframe: Day 1 Predose through Day 90

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

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

PK: Maximum Concentration (Cmax) of Ramucirumab

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

Trial details

NCT IDNCT04495478

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-09

Results submitted2022-05-06

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Timeframe: Baseline through Day 90

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

Timeframe: Day 1 Predose through Day 90

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

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

PK: Maximum Concentration (Cmax) of Ramucirumab

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