Phase 1
Completed N=50
A Study of Ramucirumab (LY3009806) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT04495478 ↗
Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Feb 2023
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 1; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 1; 0; 1; 0 | — |
| PRIMARY Number of Participants With Injection Site Reactions (ISRs) Following Subcutaneous (SC) Administration of Study Drug |
3; 3; 2; 1; 1 | — |
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Ramucirumab |
18700; 5250; 5140; 6350; 14200 | — |
| PRIMARY PK: Maximum Concentration (Cmax) of Ramucirumab |
116; 24; 20.2; 21; 46.7 | — |
Eligibility 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- Have previously participated or withdrawn from this study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
Data sourced from ClinicalTrials.gov (NCT04495478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.