CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
Ramucirumab - IV +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04495478
NCT04495478Phase 1Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Jul 31, 2020·Updated Feb 14, 2023

In Brief

A Phase 1 clinical trial evaluating Ramucirumab - IV, Placebo - IV, and 2 other interventions for Healthy. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 31, 2020
Enrollment StartJul 30, 2020
Primary CompletionMay 9, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.9 years ago

Interventions

Ramucirumab - IVdrug

Administered IV.

Placebo - IVdrug

Administered IV.

Ramucirumab - SCdrug

Administered SC.

Placebo - SCdrug

Administered SC.