NCT04495478

A Study of Ramucirumab (LY3009806) in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ramucirumab - IV	Administered IV.
DRUG	Placebo - IV	Administered IV.
DRUG	Ramucirumab - SC	Administered SC.
DRUG	Placebo - SC	Administered SC.

Timeline

• Start date: 2020-07-30
• Primary completion: 2021-05-09
• Completion: 2021-05-09
• First posted: 2020-07-31
• Last updated: 2023-02-14
• Results posted: 2023-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study